- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Associate Director , Regulatory Affairs , you will be responsible for leading RA team members involved in device project activities ... degree preferred; medical training preferred. + Minimum 8 years of regulatory affairs experience within the pharmaceutical or medical device industries, ideally with… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment ... with regulatory trends, innovation, and compliance while balancing business benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee submission planning, authoring, reviewing, and coordination for regulatory filings (eg, BLA,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …will report to the Senior Director , Strategy Lead of PAQ Oncology. The Director Medical Affairs - PAQ Oncology will support the US launch planning and ... identify and communicate data gaps, and work collaboratively with research teams ( Clinical Development, Medical Affairs Research, Value and Access Health… more
- Ascendis Pharma (Princeton, NJ)
- …part of the Regulatory Affairs team, you will report to the Senior Director Regulatory Affairs , Advertising and Promotion. There is a preference for this ... together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs , Advertising and Promotion will be an internal expert on US FDA… more
- System One (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves: + Must be local ... development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in developing and executing regulatory strategies… more
- Bristol Myers Squibb (Princeton, NJ)
- …leads matrixed cross-functional project management teams and projects within the Medical Affairs Cell Therapy Organization. This role reports directly to the Senior ... Director of Strategy and Operations, serving as a strategic...matrix. + Experience with drug development, commercialization, and healthcare, clinical trial management a plus. \#LI-Hybrid If you come… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Principal Scientist (Associate Director ) is responsible for developing and implementing Regulatory Chemistry, ... lead the preparation and submission of CMC dossiers for programs in clinical development, marketing applications and post-approval life cycle maintenance phases. The… more
- Merck (Rahway, NJ)
- …in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and Assist the Executive Director /AVP in ... medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle… more
- J&J Family of Companies (Titusville, NJ)
- …**We are searching for the best talent for a Director , Clinical Project Physician - Neuropsychiatry.** **POSITION SUMMARY:** ... project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management,… more
- Bausch + Lomb (Trenton, NJ)
- …relevant global team members, other B&L departments (eg, R&D/Project Management, Clinical /Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, ... study objectives are being met and provide the operations director and/or senior management with timely updates on progress...completed in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs … more
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