Manager Of Regulatory Affairs Jobs

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: Vice President, Quality & Regulatory Affairs Management - PET Company: Cardinal Health Location: Dublin, OH Description: JOB TITLE:VP, Quality Regulatory Affairs Management - PETAt Cardinal Health, were developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities.Function:QRAFamily:QRA ManagementWhat QRA Management contributes to Cardinal HealthQRA Management is responsible for strategic oversight and leadership direction within the QRA function

Job Title: eCTD / EDMS Manager Regulatory Affairs Company: Galderma Laboratories, L.P. Location: Fort Worth, TX Description: Manages eCTD Electronic Document Management Systems (EDMS) for Pharmaceutical Company (NDA's SPL's) ABOUT US: Created as a joint-venture between Nestle and L'Oreal in 1981, Galderma is the number one dermatology company in its markets focusing exclusively on meeting the needs of dermatology patients and physicians. This commitment translates into innovative therapeutic solutions for the diagnosis, prevention and treatment of dermatological conditions. We have an excellent opportunity for a Regulatory Affairs professional with experience with eCTD / EDMS (electronic filing) systems in the pharmaceutical environment.The position is based in Alliance which is 20 miles north of downtownFort Worth, TX. Galderma offers a very attractive package of salary, incentive pay and benefits. JOB DESCRIPTION: Manages electronic document management systems (EDMS) for regulatory activities. The systems include electronic new drug applications (NDAs), structured product labeling (SPL) and electronic drug listing. ESSENTIAL DUTIES/RESPONSIBILITIES Other duties may be assigned. Participates in the evaluation of proposed EDMS tools for possible use and purchase. Acts as the regulatory technical representative for all EDMS projects including but not limited to SPO systems, label approvals, electronic archiving, etc. Writes and maintains operating procedures describing EDMS activities at the local or US level. Provides training for users of EDMS systems at the local or US level. Assembles NDAs and drug listing submissions Provides technical expertise to assist in the assembly of submissions to NDAs, SPL and electronic drug listing. Maintains GLLP’s FDA electronic submission gateway (ESG) account. EDUCATION and/or EXPERIENCE : Bachelor's degree in life sciences or computer sciences or related field from a four-year college or university. Minimum of five years experience using electronic documentation systems. Experience with Liquent Insight Suite preferred. In order to function effectively, the incumbent must have a thorough working knowledge of the pharmaceutical industry including all regulatory requirements; the drug development process, including pre-clinical, clinical and product development; regulations describing the content and submission of drug product marketing authorizations in the United States. To APPLY for This Position CLICK HERE To view vacant positions visit our CAREERS PAGE Galderma is an equal opportunity employer M/F/D/V 11

Job Title: Manager, Regulatory Affairs Company: Discovery Solutions, Inc. Location: Chicago, IL Description: Manager, Regulatory AffairsLooking for a submissions specialist experience submitting ANDA and AADAs to the FDA.Bachelors Degree plus 3+ years submissions experiencePlease refer to job code Reg Affairs when responding to this ad.

Job Title: Regulatory Affairs Manager Company: Biotest Pharmaceuticals Location: Boca Raton, FL Description: Regulatory Affairs ManagerTracking Code1293Job DescriptionSupervises and participates in the planning, preparing and interpreting regulatory documents for submission to governmental regulatory agencies such as the U.S. Food and Drug Administration.  Serves as a liaison with regulatory agencies and contractors, as well as an information source regarding product and assay development questions.  Ensures corporate policies and procedures comply with regulatory requirements. Provides accurate and timely regulatory guidance to the R&D, manufacturing, operations and quality staff while maintaining frequent contact with the Senior Director. Responsible for preparation, review, presentation, and evaluation of all FDA submissions to assure accuracy and completeness of submission documents including meeting/briefing packages/ and presentations to the FDA (e.g., pre-IND submission, end-of-phase II, pre-market application, and advisory committee meetings), New Drug Applications (NDAs), Orphan Drug Applications, Market Applications, INDs, (product and Establishment License Applications), and other related documents or CMC section submissions. Determines submission requirements and requests needed data, information, and documentation from pertinent departments, facilities, and affiliates, and from contractors/vendors as needed. Liaises with partner companies as appropriate. Provides signatory approval for reports and amendments to INDs/BLAs, assuring submission within specified regulatory timeframes. Reviews and approves for accuracy and completeness all materials to be included in submissions, including materials prepared by others and supplied to Regulatory Affairs. Required SkillsEffective written and verbal communication skills.  General knowledge of pharmaceutical development and federal regulations in pharmaceutical principles of document management.  Excellent program management skills.  Proficient in word processing packages.  Must be able to represent Biotest Biopharmaceuticals with accuracy and sensitivity to regulatory issues.  Detailed knowledge of: Federal Food, Drug and Cosmetic Act; Code of Federal Regulations; FDA guidelines; and Regulatory Affairs department SOPs. Ability to manage junior regulatory staff membersRequired ExperienceBachelor's degree in Pharmaceutical, Biological or Chemical Science or related field. Five plus years plus of practical pharmaceutical development regulatory experience at a management level in Regulatory Affairs with an emphasis on Biologics and BLA submission experience.Job LocationBoca Raton, FL, US.Position TypeFull-Time/Regular

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: Director of Regulatory Affairs Company: Advanced Bionics Location: Valencia, CA Description: Employer Information About Advanced Bionics Advanced Bionics® Corporation is a global leader in developing the most reliable, best performing cochlear implant devices in the world. Founded in 1993, AB is the only American company developing cutting-edge cochlear implant technology that restores hearing to the deaf and allows our recipients to hear their best today, tomorrow, and always. We support patients, clinicians, and physicians through the latest scientific research, technology development, educational resources, attentive customer ....more info View all our jobs Job A. Primary Function Manage the regulatory affairs function. Generate or direct regulatory affairs specialists in the preparation of submissions to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide B. Duties and Responsibilities 1. Generate or direct regulatory affairs staff in the preparation of submissions (i.e. PMA, 510(k), CE marking applications, production registrations, etc.) to obtain various worldwide approvals to commercially distribute products. Product subsequent submissions (annual reports, PMA Supplements, change notifications, etc.) to facilitate the maintenance of these approvals. Oversee the subsequent submissions (annual reports, change notifications, etc.) to facilitate the maintenance of these approvals. 2. In conjunction with Clinical Research, prepare or direct regulatory affairs staff in the generation of applications (i.e. IDE) for conducting clinical investigations in U.S., Canada, and EU countries. Generate required submissions (progress reports, etc.) to support the continuation of clinical studies. Oversee the required submissions (progress reports, etc.) to support the continuation of clinical studies 3. Responsible for issue/complaint handling system. Ensure that all reports and information required by complaint reporting and postmarket vigilance systems are maintained and submitted. 4. Provide input to the engineering teams to assure that worldwide regulatory requirements and standards are incorporated in the product development design. 5. Participate or direct the staff in the engineering change order process, by reviewing engineering and manufacturing document release and changes.: PQRB, PIR/Field Action, RLT, CAPA, Change Board, Management Review, and Risk Management. Assess and initiate regulatory filings where needed. 6. Review and provide input to labeling and marketing programs in reference to regulatory requirements. 7. Keep abreast of new or developments in various regulations and advice senior management as necessary. 8. Interface with regulatory agency representatives as needed to accomplish the above tasks. 9. Other duties as assigned. NOTES: Local Country Candidates Only. Additional Salary Information: Salary commensurate with experience.

Job Title: Regulatory Affairs Manager Company: Aerotek Scientific Location: Chicago, IL Description: A client of ours has an immediate opening for a Regulatory Affairs Manager in the Northwest Suburbs of Illinois. The Regulatory Affairs Manager is responsible for providing regulatory support and new product development strategies and submissions for drug/device combination products. Major job duties and responsibilities:-Provide regulatory expertise and technical knowledge to fulfill requirements.-Review and approve product labeling and advertising for compliance to applicable regulatory requirements.-Interact directly with regulatory agencies to answer questions and move submissions forward. -Establish and maintain rapport with agency contacts.-Keep apprised of global regulatory requirements and inform product teams of upcoming changes in the regulations.-Provide regulatory advice, review and approval of technical documents including product specifications, clinical protocols, test plans and risk documentation.-Act as core team regulatory lead to represent regulatory affairs on assigned product and project teams and establish regulatory strategies that align with world-wide objectives.-Independently plan and manage regulatory strategies and submissions for complex new product development and change control projects.Job requirements and qualifications:-Bachelor's degree or equivalent experience. -5 years of experience in regulatory affairs including experience directly interacting with project teams. -US submission experience. (IND, IDE, NDA, 510(k), and/or PMA)-Experience managing multiple projects and deadlines.If you are interested in learning more about this opportunity please contact Mary Jo Orbegoso at Register to View or morbegos(AT)aerotek.com.Join Aerotek Scientific LLC(SM), one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.

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: Senior Manager, Regulatory Affairs Company: STERIS Corporation Location: Mentor, OH Description: Employer Information About STERIS Corporation STEIRS Corporation is a leading global manufacturer and supplier of infection prevention, contamination control, decontamination, microbial reduction, and surgical and critical care support products, technologies and services used in the military, government, emergency response, healthcare, pharmaceutical industries and laboratory research facilities around the world to safely and effectively prevent contamination and combat infectious diseases. View all our jobs Job Join STERIS in its vision to see the world free from infection and contamination as a Senior Manager, Regulatory Affairs Summary The mission of the Regulatory Affairs Submissions and Registrations function is to implement efficient and effective processes to initially obtain and then maintain registration approvals to market STERIS products in designated countries in support of STERIS’s global business plans. This includes determining registration and/submission requirements in the various markets, identifying the documentation needed to meet the identified requirements, and working closely with STERIS corporate domestic and international staff, STERIS distributors, regulatory consultant contractors and various U.S. and foreign government agencies to prepare and submit required documents, while using electronic record-keeping tools according to departmental policy. This group identifies and supports Regulatory Compliance needs in all markets. Essential Job Duties Identify and keep current with the various international country submission/registration/approval and compliance requirements for marketing STERIS products domestically and in 50+ countries outside the U.S.A. where STERIS does business. Participate and represent Regulatory Affairs on the cross functional New Product Development Teams. Develop sound global regulatory strategies for new products. Identify and communicate applicable regulatory requirements to STERIS Regulatory Affairs management and the department’s business partners from the start of product development through qualification testing and submission/registration, and as changes occur or new requirements are identified. Gather information and documentation on new or modified products to determine submission requirements for particular markets. Compile and create document packages (dossiers, 510(k)s, Technical Files, Minor Modification files) through analysis and synthesis in a standardized format to support product claims and satisfy regulatory authorities. Critically assess the strength and completeness of documentation created by others; advise improvements to comply with current requirements for particular regulatory authorities. See that all staff members maintain paper and electronic submission documents, databases, and other regulatory records in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information. Review and approve product labeling, including marketing/promotional/technical literature to ensure that all label formats, product claims and instructions for use are appropriate and consistent with cleared indications for use, product design documentation, and US and international regulations/standards as applicable. Manage the selection and use of software tools for registrations tracking and reporting, including training and support of Regulatory Affairs staff in use of IRST, Sharepoint sites, and other tools; work with IT and Customer Operations on system improvements and de-bugging. May be asked to install, configure, update, serve as administrator, and train Regulatory Affairs staff in the use of software tools to organize and manage the registration process. May be asked to serve as administrator for validation software tool – set up user access, certify that users are trained in computer system validation and use of the tool; set up new validation projects in the system, field technical questions from users. In the role of Regulatory Representative, apply regulatory knowledge and judgment to the evaluation of product modifications, communicate potential regulatory compliance issues, and assist the facility in addressing regulatory issues in a timely manner. Responsibilities include: Gathering core information from manufacturing, quality, etc. to assess the significance of a proposed product change and, when applicable, forwarding the information to Regulatory Affairs management for review; Providing technical guidance to the Quality Team establishing validation test plans and protocols and to comply with industry standards and FDA guidance documents; and Participating in cGMP compliance audits initiated by FDA, International 6 Governmental agencies, Notified Body BSI and customer inspections. Set goals, guide project activities, track progress, report status as appropriate, and take action on unexpected setbacks to avoid delays, late filings, or disruption in product availability. Working Conditions/Physical Requirements General office working conditions. Position may require approximately 20% local or international travel to STERIS facilities, government agencies, customers, trade shows or training courses. Supervisory Responsibilities The Regulatory Affairs Manager has staff management responsibilities and/or project management responsibilities. He/she will lead teams including other regulatory staff and staff from other disciplines in achieving the objectives of the assigned projects. The RA Manager will also assist with training of regulatory staff in subject areas where he/she has expertise. Nature of Problem Solving Ability to work in a highly complex environment under general direction as to assignment and occasional review. Considerable problem solving is required, including the resolution of technical questions through identification and interpretation of scientific documentation. Ability to resolve conflicts between differing priorities of various process stakeholders by formulating pragmatic solutions and obtaining consensus. Empowerment and Decision Making Environment Access to all company confidential product and business information to perform the duties of the position. Evaluates the effectiveness of policies, procedures and systems impacting the global registration of STERIS products and services, and recommends improvements to Regulatory Affairs management. Operates independently under Director’s guidance. Resolves problems of moderate to high complexity, including high impact decisions. Initiates action to achieve project goals and avoid non-compliance. Interacts daily with STERIS employees, customers and government officials from different cultures and must possess a strong cultural awareness and sensitivity. NOTES: Local Country Candidates Only. Employer will assist with relocation costs