Director Of Regulatory Affairs Jobs

Job Title: Sr. Project Manager, Regulatory Affairs Company: Mylan Inc. (Global) Location: Morgantown, WV Description: Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest – and highest quality – product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third-largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. We are currently seeking a Sr. Project Manager, Regulatory Affairs at our Morgantown, WV location. In this exciting role, the candidate will collect, monitor and report regulatory planning, submissions, review issues, approvals and regulatory trends for all regions (US, Canada, EMEA, Japan, Australia, New Zealand). Under the direction of the Sr. Vice President, Global Regulatory Affairs, the Sr. Project Manager will conduct research on regulatory issues throughout the world; prepare summary presentations, talking points and position papers on this research. The Sr. Project Manager will coordinate and complete Regulatory projects as assigned and will oversee and manage the operational aspects of these projects including design, planning, problem solving, and implementation. Additional responsibilities include: 1. Monitor on a weekly, monthly, and yearly basis regulatory submissions and approvals across all regions including monitoring review issues and regulatory trends. 2. Notify the SVP RA of significant issues arising with regulatory submissions and reviews. 3. Monitor changes in regulatory guidance and requirements throughout the regions through collaboration with the regional Regulatory groups. Prepare summaries of the proposed or implement changes for management. 4. Monitor actual regulatory spend against that budgeted for the year including closely monitoring filing fees. 5. Research regulatory issues and summarize the regulatory position of each health authority (HA) for each region including regulations, guidance and the HA’s prior decisions and actions on the given matter including a regulatory interpretation of the application of these regulations to the specific Mylan question being asked. 6. Prepare presentations for management, talking points and position papers on regulatory issues. 7. Assist SVP in monitoring daily Regulatory operations by attending and coordinating regional Regulatory meetings and reporting activities back to SVP RA. Communicate with SVP RA’s direct reports on an ongoing basis and monitor departmental goals and activities. 8. Oversees and manages regulatory projects as assigned including design, planning, problem solving, and implementation. 9. Serve as a liaison between Regulatory Affairs and other departments (ie, R&D, Quality, Commercial Ops, Manufacturing, etc.) 10. Travel is required. 11. Perform other duties as assigned Reporting Structure:

Job Title: Director of Regulatory Affairs - NDA Company: Covidien Location: Saint Louis, MO Description: Employer Information About Covidien At Covidien, we're passionate about making doctors, nurses, pharmacists and other medical professionals as effective as they can be. Through ongoing collaboration with medical professionals and organizations, we identify clinical needs and translate them into proven products and procedures. Over the years, we've pioneered a number of medical advances that spans medical devices, imaging solutions, pharmaceuticals and medical supplies, we serve healthcare needs in hospitals, long-term care and a....more info View all our jobs Job The position of Director of Regulatory Affairs, in the Regulatory Affairs Department, requires an individual with direct regulatory affairs experience and experience managing a group of regulatory professionals in the development of new drug development programs. This person will be responsible for the formation of the global regulatory strategy involving the direction and management of resources and activities in the development and implementation of regulatory strategies leading to the rapid submission and approval of high quality dossiers meeting the requirements of Health Authorities and the needs of the company; ESSENTIAL FUNCTIONS: 1. Maintains current high level knowledge of regulations, the regulatory process, and the application of regulations to assigned products - expands regulatory background through work on projects, researching available documents and attending relevant training. Anticipates how future developments in the regulations for relevant therapeutic areas may effect drug development process. 2. Liaison with regulatory agencies during the development process and for assertively and successfully prosecuting marketing applications to ensure their timely approval. 3. Oversees those activities that lead towards the submission of high quality clinical trial applications, which meet clinical development timelines. 4. Directs resources and assures that activities will lead to the provision of adequate and proactive regulatory guidance into the Core Development Teams for new product development to ensure that the resultant development package is consistent with ICH guidelines and global regulatory agency expectations for new products. 5. Interacts with key functions of the company including R&D, Clinical Development, Manufacturing, Quality Assurance and Marketing. 6. Responds to inquiries from various departments regarding regulatory strategy, post-approval changes, etc. in a timely manner. Insures proper research was conducted prior to communicating regulatory strategy. 7. Drafts, circulates, and maintains department work instructions of essential job functions. Insure compliance with procedures among staff. 8. Develops coaching partnerships with direct reports. Provides training and development plans. Generates team goals and manages yearly progress of goal completion. Provides reports with challenging assignments and opportunities to address their development needs. Provides continuous feedback and end-of-year performance review. 9. Provides training in various RA areas, including but not limited to: documentation review, EZSubs utilization, SOPs, work instructions, submission procedures, timeline management, regulatory procedures, FDA application types, review process, etc. Develops training programs for new department members. 10. Performs due diligence on Regulatory information for external collaboration projects. Provides regulatory strategy and support to contact manufacturers and partner companies, as necessary. Provides templates for document authoring and directs timeline, as appropriate. 11. Assists plant site RA with regulatory issues. Serves as liaison to site RA and QA personnel for product life cycle management. Provides regulatory requirement support and direction as necessary. Provide assistance during FDA audits as necessary. 12. Manages those activities that lead towards the submission of high quality CMC applications, facilitating pharmaceutical and clinical development timelines. NOTES: Local Country Candidates Only. Additional Salary Information: Relocation, Health, 401k, Vacation and Holiday Pay

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: Director of Regulatory Affairs Company: Lucas Group Location: Los Angeles, CA Description: Director of Regulatory Affairs Job code: 131732 Location: CA-LOS ANGELES Job Description: Director/Associate Director Regulatory Affairs Our client prepares ready-to-file registration files for custom manufactured peptide drug substances and offers professional regulatory support to customers. We hold a number of DMFs and CEP certificates for peptide drug substances in registered pharmaceuticals. The Regulatory Director/Senior Manager will lead the RA department and supervise RA activities at our site in San Diego. The RA manager will work with the other RA site managers within the organization to implement a global RA standard. The position title will be dependent of the experience of the successful candidate. This position will be based in Los Angeles directly reporting to the Chief Operating Officer. Essential Job Responsibilities: Preparation of drug substance registration files for inclusion INDs, CEPs, DMFs and NDAs Participate in process development projects and provide regulatory guidance Responsible for RA interactions with customers and regulatory authorities Lead the RA department Oversee RA activities at the site in San Diego Required Skills/Qualifications:          Minimum BSc  degree in Chemistry or equivalent 10-15 years of professional experience in the Pharmaceutical API, or API Fine Chemical industry in areas of Regulatory, Manufacturing or Quality. At least 5 years experience in Regulatory Affairs for small molecule/chemical Drug Substance filings is required.  FDA, EMEA and bulk chemical API cGMP experience Knowledge and understanding of API chemical synthesis, Quality Control and Quality Assurance Good communication skills (oral and writing) Good leadership/ management skills IMPORTANT: Please attach your resume in Word format. Apply Here

Job Title: Regulatory Affairs Manager II Company: Location: Baltimore, MD Description: Regulatory Affairs Manager II The Clinical Monitoring Research Program (CMRP) provides comprehensive programmatic/project and procurement management support to NCI's cancer Human Biobank (caHUB) program. The Regulatory Affairs Manager provides direct regulatory oversight support to the caHUB efforts of the Office of Biorepositories and Biospecimen Research (OBBR). Responsible for providing technical assistance and expert oversight for the development of regulatory strategies related to collection, annotation, storage, and profiling of tissues. Coordinates the planning, scheduling, preparation, and review of informed consent forms, material transfer agreements, and other related regulatory documents associated with caHUB. Serves as a liaison for clinical investigators and other clinical regulatory staff providing regulatory guidance as well as review and expertise to ensure documentation conforms to applicable regulations and guidelines. Responsible for monitoring key ethical and legal issues related to protection of research participants, adherence to policies for the appropriate use of biospecimens, and adherence to federal and state regulations surrounding the collection, storage, dissemination, and use of biospecimens. This position will be located in Rockville, Maryland. REQUIRED SKILLS: Possession of a Bachelors degree from an accredited college/university in a health/scientific, or medically related field or four (4) years related experience in lieu of degree. Masters degree preferred. In addition to education requirements, a minimum of eight (8) years of progressively responsible regulatory experience. Ability to work in a clinical research setting both independently and within a team to build strong relationships with multiple groups. Required to exercise good judgment in planning and accomplishing goals. Must be detail-oriented and possess strong organizational/planning skills and the ability to prioritize multiple tasks/projects. Demonstrated excellent written and verbal communication skills. Possess knowledge of clinical trial fieldwork concepts and practices as well as expertise in managing IRB submissions and approvals, expertise in HIPAA regulations, material transfer agreements, regulatory and quality assurance procedures and ICH guidelines. Proficiency in Microsoft Excel, Word, and Outlook. Must demonstrate working knowledge of scientific principles. Please respond with resume and salary requirements.

Job Title: Associate Director Regulatory Affairs - Regulatory - Manager RA Company: CyberCoders Location: New York City, NY Description: Associate Director Regulatory Affairs - Regulatory - Manager RA - Regulatory Strategy - IND/NDAIf you are an Associate Director Regulatory Affairs, Manager of Regulatory Affairs, or Sr Manager of Regulatory, with a regulatory strategy background, a PhD or PharmD and IND/NDA experience, please read on!A top, multi-national pharmaceutical company based in Northern New Jersey, is looking for an Associate Director of Drug Regulatory Affairs/ Regulatory Strategist to join their team! If you aren't local to the NYC/North Jersey Metropolitan area, but posses the requisite experience, my client will provide a comprehensive relocation package to get you there!What you need for this position:-An Advanced degree - PhD or PharmD, is strongly preferred!-At least 5+ years of experience developing regulatory strategies in the pharma industry-IND/NDA writing/filing experience-A background in Clinical development is a plus!- Focus in Clinical Regulatory Strategy - not CMCWhat you'll be doing:-Developing regulatory strategy for a global pharmaceutical company-Working hand in hand with the Director of Global Drug REgulatory affairs and with Global drug life cycle teams-Managing and developing strategy for global submissions-Lead a team of regulatory professionals through implementation of your strategies and the submission process, as well as IND/NDAWhat's in it for you:-Extremely competitive salary and bonus structure-Opportunity to work in a global organization making a direct and immediate impact on the regulatory affairs groupSo, if you are you are an Associate Director Regulatory Affairs, Manager of Regulatory Affairs, or Sr Manager of Regulatory, with a regulatory strategy background, a PhD or PharmD and and IND/NDA experience, please apply today!Must be authorized to work in the United States on a full-time basis for any employer.

Job Title: Director, Regulatory Affairs-Medical Device Company: GlaxoSmithKline Location: Parsippany, NJ Description: Employer Information About GlaxoSmithKline At GlaxoSmithKline, our goal is simple: to improve the quality of human life by enabling people to do more, feel better and live longer. Bringing our talents together, we aim to meet the healthcare needs of people worldwide. View all our jobs

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: Manager, Regulatory Affairs & Government Relations Company: Just Energy Corp. Location: Albany, NY Description: Employer:                   Just EnergyJob Title:                    Manager, Regulatory Affairs & Government RelationsDepartment:               Regulatory AffairsReports To:                Executive VP, Regulatory and Legal AffairsOrganization:             Vicinity of Albany, New York Business Profile: Just Energy is one of North America’s leading electricity and natural gas retailers with offices in the U.S. and Canada.  Through its affiliates under its parent, Just Energy Income Fund, a publicly traded Income Trust (TSX:JE.UN), Just Energy provides over 1.6 million residential, small to mid-sized commercial and small industrial customers with the peace of mind that comes from knowing that they are protected from energy price volatility.  In addition, through its subsidiary National Home Services, Just Energy sells and rents high efficiency and tankless water heaters, and through its subsidiary Terra Grain Fuels, produces and sells wheat-based ethanol.  Just Energy is poised to become an industry leader in providing environmentally responsible energy supply solutions to consumers across North America. Just Energy continues to focus on growth, professional development and fostering an entrepreneurial spirit that has made the company what it is today.  We are looking for individuals interested in joining a fast-paced, dynamic, and growing company that is also a leader in the North American retail energy market.  We offer competitive compensation with incentive bonuses, group benefits, a dynamic working environment and opportunity for growth that is unparalleled. General Summary:This position will have responsibility for implementation and ongoing administration of regulatory oversight in certain regional markets, regulatory compliance and day-to-day support to the business units in the conduct of their sales of long term natural gas and electricity contracts and home services.Key Accountabilities:Managing and monitoring regulatory activities and proceedings/applications with local regulatory bodies and local/Federal government.Establishing and maintaining effective relationships with government, regulators, utilities and market participants and advocacy role with same.Advising business units on compliance with regulations and requirements for the marketing and sale of energy, and transactional and operational rules and related developments.Participation in external energy policy and technical committees and industry forums, and advocate for the interests of the business.Participation in internal development of regulatory strategies and policies which align/support business strategies.Communication and interaction with internal business units with regards to regulatory activities and developments. Qualifications:University Degree5-10 years experience in wholesale and retail enery markets in similar roleExcellent written and verbal communication skillsOrganization and analytical skillsNegotiation skillsThe ability to manage a diverse workload and tight timeframesAbility to work effectively with little supervisionExperience in specific U.S. jurisdictions – North East and/or Mid Western StatesTravel is required in this role Application Process: If you are interested in an opportunity with Just Energy, we hope to hear from you soon.  Note that additional details about the company can be found at the following websites: www.justenergy.com and www.je-un.ca Please send resume via email to Register to View and enusre you place the name of the position in the subject of the email.

Job Title: Manager, Regulatory Affairs Company: Baxter Location: Deerfield, IL Description: Baxter is a fast-paced technology-driven company that provides its employees with opportunities for professional growth, as well as the flexibility to achieve a balance between work and personal life. As a Regulatory Affairs Manager you will have responsibility for providing regulatory strategy and support for Baxter’s Regenerative Medicine business. In this position, you will interact with a global team involved with the development and maintenance of our cellular therapy and biosurgery products. Essential Duties and Responsibilities: Develop and execute regulatory plans for complex projects including new and existing products within Baxter's stem cell, surgical sealing and hemostatic product portfolio Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks Ensure project teams and business objectives and deliverables are aligned with regulatory strategy Monitor applicable regulatory requirements, assure compliance with Baxter and external standards Assess impact of new regulations and provide feedback Gather regulatory intelligence regarding the global regulatory environment and competitive products Develop and document sound regulatory decisions and justifications Represent or lead the RA function on assigned cross-functional project teams Communicate proactively and report to regulatory authorities Maintain appropriate communication within the RA function and other functions primarily at the project team level Initiate, manage and maintain operational activities in support of new and existing marketing authorizations May provide direct supervision of individuals including mentoring and performance management May review promotional material or SOP’s for compliance with local and global regulations