- Genmab (NJ)
- …fit? Then we would love to have you join us!The Global Regulatory Labeling , Policy and Intelligence Associate Director will primarily be responsible for ... be within Global Regulatory Affairs (GRA) and will report to the Sr. Director , Labeling , Policy and Intelligence. The position may be based in our Princeton,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Gilead Sciences, Inc. (San Mateo, CA)
- … agencies. You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the Virology therapeutic ... products and indications. Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the Virology therapeutic area.… more
- Abbott (San Diego, CA)
- …for diversity, working mothers, female executives, and scientists. The Opportunity This position, Associate Director Regulatory Affairs , works out of our ... role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs. We're empowering smarter medical… more
- Bausch Health (Bridgewater, NJ)
- Associate Director , Regulatory Affairs Job Location: Hartford, Connecticut, USA | NewHaven, Connecticut, USA | Stamford, Connecticut, USA | Atlanta, Georgia, ... and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles...correctly apply them as appropriate in product development and labeling regulatory Regulatory Affairs Certification… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC...proposed preclinical, clinical and manufacturing charges. Review and approve labeling to ensure compliance. Represent regulatory affairs… more
- Kyowa Kirin North America (Princeton, NJ)
- …with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director , Regulatory Affairs, Advertising and Promotion ... product to ensure compliance with US regulatory requirements. In addition, the associate director will be responsible for supporting preparation of FDA Form… more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …to work in our office three days per week on average. Position Summary: The Associate Director (AD), Clinical Trial Materials (CTM) plays a pivotal role in the ... across Phase I-IV and investigator-initiated studies (IIS). Reporting to the Sr. Director of Clinical Trial Materials, this strategic and hands-on leader is… more
- KA Recruiting, Inc. (Houston, TX)
- …mounting (paraffin/frozen sections), staining (routine/special/IHC), slide and block labeling & coverslipping Performs special staining techniques for interstitial ... complex diagnosis and prognostic markers Contribute to corporate strategy for additional regulatory approvals (CAP, FDA, ) relating to GHI Histopathology Assess the… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About ... could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy is responsible… more
- Gilead Sciences, Inc. (Foster City, CA)
- … agencies. You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the Virology therapeutic ... indications. + Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the Virology therapeutic area. + Provides… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... of labeling documentation and assures that Takeda labeling content and processes conform to regulatory ...Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development ... and guidance and correctly apply them as appropriate in product development and labeling regulatory + Regulatory Affairs Certification by RAPS a plus The… more
- Boehringer Ingelheim (St. Joseph, MO)
- …such as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety & Efficacy will...as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION ... : Takeda Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance...of data related to the drug development lifecycle, including regulatory submissions, labeling , and product tracking; Oversee… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC...preclinical, clinical and manufacturing charges. + Review and approve labeling to ensure compliance. + Represent regulatory … more
- Abbott (San Diego, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This position, ** Associate Director Regulatory Affairs** , works out of ... RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory ...GMPs) + Principles and requirements of promotion, advertising and labeling International treaties and regional, national, local and territorial… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …become your best self. Become a **maker of possible** with us. **Job Overview** The Associate Director of Regulatory Affairs will provide regulatory ... activities, developing and maintaining documentation for compliance programs such as labeling , promotional material review, and other regulatory requirements.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- Edwards Lifesciences (Irvine, CA)
- …we are supporting the needs and interests of the patients we serve. The Senior Director , Corporate & Regulatory Counsel role is a blend of subject matter legal ... expert and strong business acumen. The Senior Director , Corporate & Regulatory Counsel will have...in Irvine CA and reporting to Senior Vice President, Associate General Counsel, TAVR General Counsel. The successful candidate… more
