- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Regulatory Affairs Associate Director , you will be responsible for leading RA team members involved in device project ... degree preferred; medical training preferred. + Minimum 8 years of regulatory affairs experience within the pharmaceutical or medical device industries, ideally… more
- GRAIL (Washington, DC)
- …and healthcare companies. For more information, please visit grail.com . The Associate Director of Global Regulatory Affairs & Safety serves as a key ... Experience of working in IVD, medical device, or pharma industries in regulatory affairs /quality roles with experience of regulatory submissions and safety.… more
- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will ... CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine… more
- Rhythm Pharmaceuticals (Boston, MA)
- …to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be ... and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities and Duties + Act as the Global… more
- Abbott (San Diego, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** This position, ** Associate Director Regulatory Affairs ** , works ... team, reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and economic decision-making to help transform the… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- AbbVie (Mettawa, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs US Advertising ... cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Friday remotely on a weekly basis. **Summary of Job Responsibilities** The Associate Director of Regulatory Affairs will provide regulatory support ... regulatory strategies for new product submissions, project management for regulatory affairs submissions, handling existing product registrations including… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Associate Director of Regulatory Affairs , you will lead regulatory activities for new product development, labeling ... the United States. This position reports to the Vice President of Global Regulatory Affairs . **Job Description** We are **the makers of possible** BD is one of… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs , Neuroscience is responsible for ... regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How you...and Takeda R&D. **How you will contribute:** + The Associate Director will be responsible for increasingly… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director of Regulatory Affairs - Soft Tissue Fillers supports ... regulatory interactions with R&D, Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory policy, intelligence… more
- Boehringer Ingelheim (St. Joseph, MO)
- …governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety &...as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and… more
- United Therapeutics (Madison, WI)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute 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… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategies in collaboration with their regional counterparts. **Accountabilities:** + The Associate Director will be responsible for complex or highly complex ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... regulatory filings for cellular & gene therapy projects (CAR...be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary:** Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products. **Responsibilities:** _CDx development_ _:_ Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and ... Director is committed to encouraging continuous improvement in regulatory practices, operational efficiency, and personnel development within the GRA-CMC… more