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  1. Senior Clinical Trial Manager / Associate Director, Clinical Operations at AKCEA Therapeutics

    Must be comfortable independently managing clinical trials through the use of vendor(s) delegated responsibilities for activities such as, monitoring, site...

  2. Director, Quality Assurance at PixarBio Corporation

    The Director, Quality Assurance, will report to VP Regulatory Affairs. Reviews and approves reports and other documentation prepared by QA and QC for regulatory...

  3. Senior Director, Regulatory Affairs Vaccines (RAV), New Development Programs - Vaccine Business Unit at Takeda Pharmaceuticals

    The Senior Director, Regulatory Affairs Vaccines (RAV), New Development Programs leads and drives strategy for the regulatory evaluation of New Development...

  4. Pharmacovigilance Benefit Risk Physician – Vaccine Business Unit at Takeda Pharmaceuticals

    Proven collaborative internal relations with Clinical Development, Regulatory Affairs, Medical Affairs, Quality and Legal Counsel.High integrity, sense of...

  5. Regional Physician - Vaccine Business Unit (LatAm Region) at Takeda Pharmaceuticals

    Pays special attention to serious adverse events, pregnancies, AESI’s (adverse events of special interest) and potential safety signals.Serves as a counterpart...

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    1. Project Manager- Quality/Regulatory Affairs (3958)

      Qualifications:• Advanced degree in scientific discipline or equivalent: PharmD, PhD, MD or RN • At least 5 years related experience as well as ≥3 years of experience in a pharmaceutical, medical device, or biotech company. Strong Project manager experience is required. • Supervisory or clinical experience is highly desirable. • Knowledge of client product lines/therapeutic areas (Hematology; ...

    1. Associate Director/Director- Grants Managment at Genzyme

      Develop and implement continuous training for all representatives involved in Genzyme's medical affairs grants processes to ensure all documented policies and...

    1. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

    1. Senior Specialist, Regulatory Operations at Alexion

      Associate Director, Regulatory Operations. Coordinates with Regulatory Affairs and external vendors processing timelines and handoffs to ensure timely...

    1. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

    1. Development Team Lead (Pharmaceutical Dev) at Cambridge Oncology

      Prior regulatory submission experience at the IND and NDA level required. At late stages of development, the DTL may interface with medical affairs and...

    1. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

    1. Quality Engineer 1 at Becton Dickinson & Company

      Typical degree in Biological Sciences, Chemistry, Engineering, Computer Science and/or Regulatory Affairs or other related field....

    1. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

    1. Pharmacis Quality Engineer Job at 3M

      Coordinate with production Pharmacist & Regulatory Affairs person ( Local & oversea) to support registration process....

    1. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

    1. Field Development Agronomist - Agronomist at Arkema Americas

      Technical leadership (to include design and execution of Paladin Field R&D) within the area of expertise to Sales, Marketing and Regulatory Affairs for the U.S....

    1. 99328 -Senior Manager/Associate Director, Regulatory Affairs, Labeling

      Overview:Seeking a qualified, highly motivated, experienced individual for the position of Senior Manager/Associate Director, within our Regulatory Affairs group to report into the Director, Regulatory Affairs. This individual will be responsible for providing strategic and operational leadership in the area of advertising, promotion and labeling primarily pertaining to US marketing ...

    1. BioStatistician-C-STARS Cincinnati at BTL Technologies Inc.

      Training in human subjects’ protections, regulatory. Affairs, and data collection is highly desirable. *THIS POSITION IS CONTINGENT UPON CONTRACT AWARD**....

    1. Regulatory Affairs Associate II

      - Responsible for submission activity on several programs- Report to head of submissions group, work with Regulatory Development managers on each program- Responsibilities include:- Act as liaison to CRO- Work with CRO to file initial CTAs (clinical trial applications) and amendments- Tracking of CTA filings and approvals- Coordinate Query Management- Attend SMT meetings for relevant clinical ...

    1. Sterilization Assurance Director at Medtronic

      Partner with research, product development, operations and regulatory affairs functions to ensure new products meet all necessary requirements....

    1. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

    1. GMA Strategic Planning Lead - Learning & Launch Operations at Shire

      Represent Medical Affairs at internal and external meetings. Provide medical affairs and R&D inputs for product(s) to Product Strategy Team....

    1. Sr. Associate II Regulatory Affairs - 16-00231

      Our client in Cambridge, MA is looking for a Sr. Associate II Regulatory Affairs. This is a long term consulting position. If interested, Please apply to this adPosition: Sr. Associate II Regulatory AffairsLocation: Cambridge, MAJob#: 16-00231Job description: Sr. Associate II Regulatory Affairs Company uses cutting edge science to Client, develop, manufacture and market biological medicine ...

    1. Sr QA Associate Clinical Quality Assurance (GVP) at Alkermes, Inc.

      Participate in internal Clinical Development, Biometrics, Drug Safety, Medical Affairs and Regulatory Affairs Systems audits, Commercial system audits related...

    1. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

    2. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

    3. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

    4. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

    5. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

    6. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

    7. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

    8. Global Regulatory Affairs Leader

      Our client has engaged us to help them identify a Global Regulatory Affairs Leader to join their team. Join an exciting, growing, cutting-edge company who strongly supports the development of employees as leaders and lead global regulatory projects/strategies. In this role you will work on products that have high promise of diagnosis of Parkinson's and Alzheimer's diseases.Responsibilities ...

    9. Regulatory Affairs

      The Manager, Regulatory Affairs is responsible for generating and submitting all the regulatory and registration applications to allow the company to market its products domestically and internationally.  The RA Manager develops and plans strategies to obtain regulatory approvals/clearances to market products.         General Responsibilities:•    Manages the Regulatory Affairs activities for ...

    10. Senior Regulatory Affairs Specialist

      We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team: 1) Ensure compliance of labeling and advertising for all products in a regulated class 2) Manage documentation control process and documentation change control process 3) Conduct internal audits and ...

      1. Senior Manager, Public Relations at PixarBio Corporation

        Coordinates Legal, Medical and Regulatory internal review process for materials developed. Potential litigation, product discontinuation and supply issues and...

      2. Manager, Global Regulatory Development - Oncology at Takeda Pharmaceuticals

        Proactively identifies regulatory issues; The Regulatory Affairs Manager will plan, manage and execute all regulatory activities of all levels of complexity for...

      3. Director, R&D Compliance at Takeda Pharmaceuticals

        Responsible for providing strategic input into Global Compliance Policies and SOPs that affect US-based CMSO employees.Anticipates changing industry regulatory...

      4. Global HCP Product Director/Sr. Director Dupilumab - Atopic Dermatitis at Sanofi

        Ensure that the marketing processes, programs, and internal reports are developed, implemented, and effectively administered to be consistent with corporate...

      5. Program Manager at Solid GT

        Understanding of the regulatory process for a new drug application and organization of data for regulatory interaction....