Director Of Regulatory Affairs Jobs in Pennsylvania

Job Title: Regulatory Affairs Manager Company: MedFocus Pharm. Res.Opp. Location: Wayne, PA Description: REGULATORY AFFAIRS MANAGERCOMPANY INFO:MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.Our client focuses its business on attention deficit and hyperactivity disorder, human genetic therapies and gastrointestinal diseases and is seeking to add a Regulatory Affairs Manager to their team in Wayne, PA.RESPONSIBILITIES:•    Offers strategic and operational regulatory support to preclinical, clinical, manufacturing, quality assurance and marketing departments.•    In collaboration with management, develops and reviews regulatory strategy for operational efficiency.•    Negotiates and makes agreements on behalf of the department.•    Interprets applicable regulations and guidelines for project team use.  Keeps project team abreast of regulatory decisions, issues, potential problems and new regulations.•    Provide regulatory review of promotional materials and ensure compliance with federal regulations and corporate SOPs.•    Responsible for investigational and post-approval submissions associated project, including safety reporting, CMC, and labeling responsibilities.•    Ensures timely submission of appropriate regulatory documents individually, as a regulatory team, or through contract organizations.•    Coordinates and solicits components of the submission from various functional areas.•    Raises major project issues to management for resolution and agreement.  •    Work efficiently and effectively within regulatory team, fostering collaborative exchanges, teamwork, and mentoring of colleagues. •    Attends company advisory panel meetings, investigator meetings and kick-off meetings as required.•    Mentors other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff.•    Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses.•    Complexity and Problem Solving•    Decisions on regulatory strategy are to be made by this individual.  Decisions of significant strategic impact must be discussed to supervisor.•    Position is accountable to supervisor.  Internal contacts may include PST members, BU representatives, R&D functional representatives, Legal, Supply Chain, and Program Management.  •    External contacts may include health authorities, vendors, and consultants retained by company•    Some domestic and potential international travel required.QUALIFICATIONS:•    Bachelor’s degree is required. Scientific/health care field preferred, but not required. •    Generally has at least 7 years of related experience within a pharmaceutical company, CRO or similar organization and at least 2 years of management experience; or equivalent combination of education and experience.  •    Generally has at least 4 years direct regulatory affairs experience.•    Must have experience in drug promotional review, including consumer and professional venues.•    Must be able to communicate comfortably and effectively with regulatory authorities.•    Must have extensive experience effectively working in team environment. •    Ability to work successfully within a cross-functional team.•    Must be able to independently present complex information to company senior management, CROs, regulatory authorities and the medical community.•    Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.  •    Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands. •    Ability to work independently, take initiative and complete tasks to deadlines.•    Proven ability to independently resolve problems. •    Strong knowledge of MS Word, Excel, PowerPoint, Project and Outlook.MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.

Job Title: Sr. Regulatory Affairs Manager Company: B. Braun Medical Inc. Location: Breinigsville, PA Description: Aesculap is the largest worldwide supplier of surgical instruments and implants for all disciplines including neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, spine, laparoscopic, general surgeries and central processing. We were founded in Germany in 1867 and have been in operation in the U.S. since 1977. Our U.S. corporate office is located in Center Valley, Pennsylvania. Aesculap, Inc., has an excellent opportunity for a Sr. RA Manager for our NOVOCART Division.SUMMARY:Responsible for authoring and managing regulatory submissions for NOVOCART. Serves as key point of contact for FDA and State Agencies for Aesculap Implant Systems, LLCESSENTIAL DUTIES AND RESPONSIBILITIES: • Provides regulatory oversight and preparation of documents and reports for the FDA and states’ submission processes in support of Biologics’ licensure. • Ensures success of the clinical programs through effective regulatory oversight for internal and external collaborators, including Scientists, Manufacturing, Project Managers, Quality Assurance, and consultants. • Provide oversight and guidance for staff in the preparation of CMC and Clinical sections of INDs, BLAs, and CTDs.• Schedules and facilitates applicable meetings with the FDA and other regulatory agencies to clarify and address regulatory requirements. • Utilize Quality By Design and Risk Management approaches wherever possible to set expectations for Quality Assurance, Quality Control, and Manufacturing. • Preparation and filing of adverse event reports and deviations with regulatory authorities.• Adhere to good documentation practices to ensure data integrity and traceability.• Serve on NOVOCART project teams.• Other duties may be assigned.OTHER DUTIES AND RESPONSIBILITIES:• Must be able to travel (automobile and air transport). • Must be able to occasionally travel on weekends • Ability to work with or use Personal Computer, printer, photocopier, facsimile machine, telephone, Microsoft products, SAP and Lotus Notes • This position requires the handling of instruments that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.SUPERVISORY RESPONSIBILITIES:Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problemsQUALIFICATIONS:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION/EXPERIENCE: • PhD in Pharmacy, Immunology, Biochemistry, or related discipline or M.S. with relevant experience. B.S. with extensive regulatory experience in Biologics, Cell Therapy or aseptic Pharmaceutical may be considered. • 10+ years of related experience required with a track record of successful regulatory submissions for Biologics, Cell Therapy or Pharmaceuticals. • Working knowledge of GCP/GMP/GTP/QSRs.• Working knowledge of Quality By Design and Risk Management philosophies as applicable to advanced clinical development of biologics. • Excellent interpersonal skills and the ability to work effectively in a team environment. LANGUAGE AND MATHEMATICAL SKILLS; REASONING ABILITY: Language Skill: Ability to read, analyze, and interpret common scientific, medical and spine journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, sales force, surgeons, and/or boards of directors. Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to deal with multiple problems at one time. PHYSICAL DEMANDS:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Note: Physical demands in this section may vary by job title, name all that apply to the specific job.While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. WORK ENVIRONMENT:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderateAesculap offers an excellent benefits package, which includes healthcare, a 401(k) plan, company sponsored pension and tuition reimbursement. To learn more about Aesculap and our products, please visit us on the internet at www.aesculapusa.com. An EOE.

Job Title: Regulatory Affairs Manager Company: Fortune 250 - Medical Device Company Location: Philadelphia, PA Description: The role of the Regulatory Affairs Manager is to develop and execute sound regulatory strategies for complex Regulatory Affairs programs, with emphasis on FDA and worldwide regulatory submissions. The Regulatory Affairs Manager of this global medical equipment business will work with cross-functional teams through all phases of product development from initial concepts through the FDA approval process to the product launch to deliver cutting edge medical equipment. The Regulatory Affairs Manager will be a hands on manager that will serve on core teams, leads extended core teams, acts as the regulatory expert, helps to interpret regulations/guidances, manage and mentor Regulatory Specialists.  Communicates the impact of international regulations to the regulatory team product development, manufacturing, and/or the commercial organization.  The Regulatory Affairs Manager works on problems of high complexity, where analysis of situations or data requires an in-depth evaluation of various factors.  He/she exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.   This is an exciting opportunity to lead, educate and drive large teams in a global medical technology environment.   Key ResponsibilitiesResponsible for all product FDA 510(k) submissions, technical files for foreign product  registrations, Certificates of Free Trade for foreign product registrations and legalization of regulatory documentation. Responsible for the internal Regulatory documentation processes to meet FDA requirements including the MasterControl database. Must have the ability to handle unforeseen crises with quick analysis and decisive direction. Responsible for training of new employees on FDA and ISO requirements. Represents the company during external inspections by UL, ISO and FDA. Acts as regulatory liaison during new product development.  Education BA / BS Required; MS preferred   Work experienceExperience in the medical device or pharmaceutical industry in the regulatory arena.  Four years minimum experience preparing 510(k) submissions for medical devices. Prior experience in dealing with FDA and ISO inspections; Four years minimum experience registering medical devices in Europe, Asia, and Latin America

Job Title: Group Manager, Regulatory Affairs Company: Globus Medical Inc. Location: Audubon, PA Description: The Group Manager, Regulatory Affairs, is responsible for writing, submitting and gaining approval of IDE, PMA and 510(k) submissions to the Food and Drug administration (FDA) for class II and class III products. This position entails being the primary contact with FDA, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive and effective in building working relationships with Globus Product Development teams and the FDA. This individual must adhere to FDA 21 CFR regulations in all duties. Experience should demonstrate dependability, flexibility and professionalism. Individual must be able to travel at least 10-20% of the time.               Primary Responsibilities·        Creating and executing optimized regulatory strategy including study design, protocol development, IDE / PMA submissions, and reports to ensure most efficient approval times and most favorable labeling in terms of indications and reimbursement for Class III products.·        Complete IDE and PMA submissions to FDA, for ultimate premarket approval.·        Prepare and file FDA reports.·        Prepare final 510(k) submission and obtain required management approvals.·        Work with Product Development and management to prepare and review 510(k) submissions.·        Submit 510(k) documents and responses with FDA in a timely manner.·        Complete Regulatory Pathway Form (RPF) determinations for all new and revised products, under departmental guidelines. File RPFs and supporting documentation.·        Review and file Note-to-File documentation for minor changes to 510(k) cleared products or systems.·        Ensure conformance to 21 CFR regulations.·        Assist in development of relevant regulatory SOPs.·        Understand spinal surgical techniques and the use of spinal implant/instrument systems. Qualifications ·        Master’s degree in engineering or science-related field, or equivalent.·        Minimum of 5 years experience in the medical device or pharmaceutical industry, or equivalent.·        Minimum of 3 years experience in Regulatory Affairs in medical device industry, or equivalent, preferably with spinal devices.·        Demonstrated experience in a complete cycle of the approval process for a PMA medical device product (preferably spinal) including study design, IDE submission, PMA application process, panel meeting, and approval.·        Excellent verbal,  written and organizational skills.·        Good computer skills.      Must have previous people management experience·        Must be detail-oriented.Interested candidates should apply online at  http://tbe.taleo.net/NA5/ats/careers/requisition.jsp?org=GLOBUSMEDICAL&cws=1&rid=314

Job Title: Associate Director, Regulatory Affairs Company: Johnson & Johnson Location: Fort Washington, PA Description: Employer Information About Johnson & Johnson Johnson & Johnson, through its operating companies, is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 200 Johnson & Johnson operating companies employ approximately 117,000 men and women in 57 countries and sell products throughout the world. View all our jobs Job McNeil Consumer Healthcare, Division of McNeil-PPC, INC, a member of the Johnson & Johnson's Family of Consumer Companies, is currently recruiting for an Associate Director, Regulatory Affairs located in Fort Washington, PA. McNeil Consumer Healthcare markets a broad range of over-the-counter (OTC) products, including ZYRTEC® and BENADRYL® allergy medicines, the TYLENOL® line of pain, cough-cold, and sleep medicines, IMODIUM® A-D anti-diarrheal, SUDAFED® nasal decongestants, MOTRIN® IB, and ROLAIDS® antacid products. The Associate Director, Regulatory Affairs will be responsible for providing regulatory expertise and support to assigned brands within the Allergy and Cough-Cold franchises. This individual will be responsible for providing direction and regulatory guidance to new product development (NPD) teams, facilitating implementation of NPD regulatory strategies including required FDA submissions, and collaborating with colleagues in Legal, Medical, Marketing, and Operations in the development of innovative packaging and claims for new and existing products. The Associate Director, Regulatory Affairs will also ensure high quality regulatory submissions (IND's (Investigation New Drug) and NDA's (New Drug Applications, supplements, annual reports, PADERs, FDA meeting background packages, etc.), negotiations and interactions with FDA personnel on assigned projects in consultation with the regulatory leadership team, review/approval of OTC product labeling for assigned brands, Company Core Data sheet development for assigned OTC ingredients, and SOP development/updates as required. The Associate Director, Regulatory Affairs will have Regulatory responsibility at Promotional Review Committee for review/approval of promotional materials such as print and broadcast ads, web-based promotion, press materials, professional marketing campaigns and educational pieces for assigned brands.

Job Title: Manager, Regulatory Affairs North America Company: VWR Funding Location: West Chester, PA Description: associates beyond the competitive paycheck and great benefits. For example, you'll find a large number of associates who have been with us for 10, 20, and even 30 years - the result of true growth opportunities. There has to be a reason for such loyalty, and it probably runs a lot deeper than simple numbers on a paycheck. Maybe it's because they love the feeling of knowing they matter, and their accomplishments are valued. Maybe it's something different. But whatever it is, we do know one thing: We have it at VWR International!   Description: Develop and implement regulatory policy. Set work schedules, development plans and priorities of direct reports. Monitor Regulatory Changes. Manage and Plan workload for self and direct report(s). Oversee Regulatory Compliance for Canada and FDA Regulations. Oversee Regulatory Issues for Transportation of Hazardous Materials/Dangerous Goods.   Job Requirements: Serve as Regulatory expert on Food and Drug Administration regulations. Responsible for knowledge of and analysis of changes to the wide variety of FDA regulations that impact VWR. Advise associates concerning the regulatory requirements of new and existing products subject to FDA regulations.  Oversee Canadian Regulatory Compliance Activities. Manage Regulatory Analyst who interfaces with Canadian Operations, governmental agencies and consulting agencies Recommend process changes and new processes to assure compliance Monitors regulatory changes that will impact regulatory compliance; Support warehouse activities on safety and compliance issues. Manage Regulatory Analyst who interfaces with warehouses Recommend process changes and new processes to assure compliance Monitors regulatory changes that will impact regulatory compliance; Oversee and Manage Regulatory issues that arise for Mexico and Puerto Rico Desired Experience: Science Degree with 5-7 years of experience regulatory compliance relative to the distribution of chemicals and/or biological materials.  3-5 years Supervisory experience Knowledge of FDA regulations pertaining to drugs and/or medical devices, DOT, IATA and/or TDG transportation of Hazardous materials, and experience with Canadian regulations (i.e. Health Canada, Environment Canada, Transport Canada (TDG), Canadian Nuclear Safety Commission regulations).  Ability to work with and manage people Computer skills including Word, Excel and Access Knowledge of Regulatory Compliance and good interpersonal skills  Regulatory Training in skilled areas Understanding of regulatory requirements for chemicals in distribution systems.   EOE M/F/D/V VWR maintains a drug-free workplace VWR and design are registered trademarks of VWR International, LLC VWR International, LLC is aware of fraudulent e-mails referencing VWR job opportunities. Please note: VWR does not hire employees through e-mail solicitation and never requests any employee to cash money orders or send money to others. If you question the legitimacy of a job opportunity, you can verify all job opportunities for the US and Canada by calling the VWR Career Center.

Job Title: Associate Director/Director of Regulatory Affairs Advertising and Promotional Review Company: Klein Hersh International Location: Philadelphia, PA Description: Associate Director/Director of Regulatory Affairs Advertising and Promotional Review Our client, located in the Philadelphia, PA area, is a biotech organization focusing on drug discovery and development in the areas of oncology and inflammation.  They are experiencing significant growth and looking to add key members to the organization.  If you are a regulatory advertising and promotional professional looking for your next challenge, this could be the place for you. Job Responsibilities: Establish and manage the advertising and promotional functions within the organization Responsible for directing post-marketing regulatory activities. Interact with DDMAC routinely and regulatory agencies on post-marketing subject matter. Provide regulatory, operational, and management expertise for post-marketing activities. Knowledge of pre-marketing regulations and able to provide support on ongoing pharmaceutical development programs. Assist in the marketing of regulatory strategy and manages the regulatory aspects of the program and people contributing to the program. Provide regulatory oversight in the development, review, and approval of presentations and materials to be used by medical liaisons and other scientific staff. Responsible for professional development of regulatory staff. Requirements: Job Requirements: B.S./M.S. in Life Science (PharmD preferred) with a minimum of five to eight (5-8) years regulatory affairs experience. Prior regulatory experience with US labeling, promotion and advertising      reviews, strategy for marketed products, and interaction with DDMAC required. In depth understanding of regulatory processes, procedures, guidelines and regulations Must be able to function as the regulatory expert on post-marketing, advertising and promotion Good understanding of the drug development process Experienced in presenting information at internal and external meetings. Compensation: $157,000.00 (compensation commensurate with experience and salary history). Annual target bonus, stock options, comprehensive benefits package and relocation assistance. For confidential consideration, please forward your resume in a Word document to: mailto: Register to View   only qualified candidates will be contacted. Visit www.kleinhersh.com to view other job opportunities available through our company.

Job Title: Dep Director, Regulatory Affairs Company: Sanofi Pasteur Location: Swiftwater, PA Description: The Deputy Directory, Regulatory Affairs is commonly referred to as the (global) Regulatory Product Manager (gRPM/RPM) who has the lead responsibility of one major project or several projects in the REG DEV group. The position will meet the responsibilities of a (global) Regulatory Manager/Deputy Director by serving on local and global clinical development and market expansion project teams, representing the Regulatory Affairs department, preparing, drafting, and reviewing submission-grade documents for project and regulatory files (INDs, CTAs, BLAs, CTDs, etc.), performing change control reviews, preparing regulatory impact assessments and regulatory strategies, managing interactions with health authorities (USFDA-CBER, EMEA, Health Canada-BGTD, and other international agencies). The position will manage and/or advise other regulatory affairs staff.The Deputy Directory, Reg Affairs, is mandated to take the initiative to organize and lead contacts with regulatory agencies or third parties and is responsible for the notification and inclusion of the most appropriate individuals within the company based upon the criticality of the issues to be addressed. The position may also participate in managing and developing staff in the Regulatory Affairs department.Main focus/challenge will be on the development and execution of the regulatory strategy for the assigned components of regulatory applications and submissions and for the management and coordination of various regulatory activities through the life of the project/product.We are an equal opportunity employer M/F/D/V. REQUIREMENTS - QUALIFICATIONS: Dep Director, Regulatory Affairs - BA/BS in Biology, Life Science, or related field of study required; MA/MS and/or PhD in related field or equivalent experience preferred. 5-8 years prior Regulatory Affairs or related experience required, 8-10 preferred.- Demonstrated experience with microbiology, immunology, virology or bacteriology preferred. Experience working on Project teams. Ability to manage multiple priorities efficiently. Requires in depth knowledge and understanding of the North American, European and International regulations/guidelines. Limited travel may be requiredSanofi Pasteur

Job Title: Sr. Regulatory Affairs Manager / 1839 Company: Aesculap Implant Systems, Inc Location: Breinigsville, PA Description: Aesculap is the largest worldwide supplier of surgical instruments and implants for all disciplines including neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, laparascopic, general surgeries and central processing. We were founded in Germany in 1867 and have been in operation in the U.S. since 1977. Our U.S. corporate office is located in Center Valley, Pennsylvania. Position Description:Aesculap is the largest worldwide supplier of surgical instruments and implants for all disciplines including neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, spine, laparoscopic, general surgeries and central processing. We were founded in Germany in 1867 and have been in operation in the U.S. since 1977. Our U.S. corporate office is located in Center Valley, Pennsylvania. Aesculap, Inc., has an excellent opportunity for a Sr. RA Manager for our NOVOCART Division.SUMMARY:Responsible for authoring and managing regulatory submissions for NOVOCART. Serves as key point of contact for FDA and State Agencies for Aesculap Implant Systems, LLCESSENTIAL DUTIES AND RESPONSIBILITIES: • Provides regulatory oversight and preparation of documents and reports for the FDA and states’ submission processes in support of Biologics’ licensure. • Ensures success of the clinical programs through effective regulatory oversight for internal and external collaborators, including Scientists, Manufacturing, Project Managers, Quality Assurance, and consultants. • Provide oversight and guidance for staff in the preparation of CMC and Clinical sections of INDs, BLAs, and CTDs.• Schedules and facilitates applicable meetings with the FDA and other regulatory agencies to clarify and address regulatory requirements. • Utilize Quality By Design and Risk Management approaches wherever possible to set expectations for Quality Assurance, Quality Control, and Manufacturing. • Preparation and filing of adverse event reports and deviations with regulatory authorities.• Adhere to good documentation practices to ensure data integrity and traceability.• Serve on NOVOCART project teams.• Other duties may be assigned.OTHER DUTIES AND RESPONSIBILITIES:• Must be able to travel (automobile and air transport). • Must be able to occasionally travel on weekends • Ability to work with or use Personal Computer, printer, photocopier, facsimile machine, telephone, Microsoft products, SAP and Lotus Notes • This position requires the handling of instruments that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.SUPERVISORY RESPONSIBILITIES:Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problemsQUALIFICATIONS:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION/EXPERIENCE: • PhD in Pharmacy, Immunology, Biochemistry, or related discipline or M.S. with relevant experience. B.S. with extensive regulatory experience in Biologics, Cell Therapy or aseptic Pharmaceutical may be considered. • 10+ years of related experience required with a track record of successful regulatory submissions for Biologics, Cell Therapy or Pharmaceuticals. • Working knowledge of GCP/GMP/GTP/QSRs.• Working knowledge of Quality By Design and Risk Management philosophies as applicable to advanced clinical development of biologics. • Excellent interpersonal skills and the ability to work effectively in a team environment. LANGUAGE AND MATHEMATICAL SKILLS; REASONING ABILITY: Language Skill: Ability to read, analyze, and interpret common scientific, medical and spine journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, sales force, surgeons, and/or boards of directors. Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to deal with multiple problems at one time. PHYSICAL DEMANDS:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Note: Physical demands in this section may vary by job title, name all that apply to the specific job.While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. WORK ENVIRONMENT:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderateAesculap offers an excellent benefits package, which includes healthcare, a 401(k) plan, company sponsored pension and tuition reimbursement. To learn more about Aesculap and our products, please visit us on the internet at www.aesculapusa.com . An EOE.

Job Title: Regulatory Affairs Mgr - Pharma Company: Top Echelon Network Location: Lancaster, PA Description: CHARACTERISTICS OF THE CLASS:The incumbent is responsible for providing the management of the Worldwide Department for the COMPANY Professional/Pharmaceutical Division. This job function includes insuring the establishment of regulatory standards and regulatory direction/guidance for the COMPANY Professional/Pharmaceutical Division. The primary responsibility is to develop and maintain appropriate global regulatory systems, standards and processes, and to establish successful relationships with global regulatory agencies. The position includes regulatory responsibilities for pharmaceuticals.ESSENTIAL DUTIES: Day-to-day management of Worldwide Regulatory Affairs Department. Assist in identifying, assessing, implementing and managing all necessary regulatory needs of the division with contract manufacturers through the regulatory activities of an ongoing pharmaceutical division. Prepare, compile and submission of domestic and international regulatory submissions and reports for new products, maintenance of established product lines and modifications to established products. Provide Regulatory Affairs consulting in support of global submissions. Act as Corporate liaison with worldwide regulatory agencies. Ensure that any process change that requires regulatory approval is identified and submitted to the proper regulatory authorities prior to implementation. Liaise with global marketing authorization holders to manage and ensure compliance of regulations and submissions and provide regulatory strategy as required. Conduct ongoing regulatory intelligence program which identifies the current regulatory global environment with providing impact assessment requirements that can affect the COMPANY Pharmaceutical business. Management of Worldwide Regulatory Contract Research Organizations (CROS). Development and maintenance of divisional regulatory affairs/compliance SOPs. Coordination and management of divisional product labeling systems. Supervision of Regulatory Affairs staff. Act as regulatory resource for the division. May be responsible for reviewing, documenting, logging, maintaining and/or initiating the investigation for potentially serious complaints. Manages personnel within group with responsibilities to include staffing, performance management, development and coaching, training, and application of policies, programs, and procedures. Assures that a positive employee relations environment is maintained through effective communication. MINIMUM QUALIFICATIONS: A Bachelor of Science Degree in Life Science or a related field. An advanced degree is preferred. A minimum of 6 years experience in (a pharmaceutical regulatory environment or CRO or Biopharmaceutical industry (CFR parts 210/211-Delete this reference to the regulations), including start-up of contract manufacturers, regulatory compliance and submissions. Working knowledge of regulatory affairs and the FDA, current cGMPs/GCPs and GLPs, pharmaceutical product testing requirements, FDA and ICH guidelines. Strong hands-on experience with worldwide regulatory planning and submission preparation and negotiation. A Regulatory Affairs Certification (RAC) is preferred, but not required. Strong organizational skills, basic computer skills (i.e. Word, Excel, Internet, Lotus Notes, QUMAS, Trackwise) and communication skills. Travel 10% of the time is required, both domestic and international. Ability to work in worldwide, multicultural organization.PHYSICAL REQUIREMENTS: Able to use standard computer equipment. Able to stand and sit for minimum 15 minute periods.WORKING CONDITIONS: Occasional exposure to pharmaceutical manufacturing environment. Travel is required.   See all jobs in Lancaster PA