- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience ... immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team...the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and headquarter departments to accomplish company… more
- Merck & Co. (North Wales, PA)
- …review divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and ... Job DescriptionReports to the Director /Senior Director in the Office of...corporate standards and policies and business objectives.Actively- participate in labeling and global regulatory team meetings to… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Legal Director (FDA promotion/ Labeling Drugs & Vaccines) The position provides legal support to the Human Health Division, ... with a focus on counseling clients in the areas of FDA promotion and labeling of drugs and vaccines.- The position also provides legal support to the Research… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with ... and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for...will be overall responsible for ensuring compliance with US regulatory requirements for labeling , and for coordinating… more
- AbbVie (Lake Bluff, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Regulatory Affairs , Strategic Global Labeling - Combination Products ... documentation for healthcare providers and end user. Under the Director of Strategic Labeling , they establish combination...trends and best practices in combination product and device regulatory affairs , review and comment on changing… more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director Regulatory Affairs , Strategic Global Labeling , combines the knowledge ... Director of Strategic Labeling , establishes labeling policy compliant with changing regulatory environment....labeling environment. + Under the direction of the Director , Global Labeling , provides regulatory … more
- Gilead Sciences, Inc. (Boston, MA)
- …impact. Join Gilead and help create possible, together. **Job Description** Job Description Regulatory Affairs Labeling is a core function within Gilead's ... acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates,...will be filled as a Senior Manager or Associate Director , based on candidate experience. **REQUIREMENTS:** We are all… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team...the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …consistency with product labeling and with all applicable regulations. TheSenior Director , Commercial Regulatory Affairs will stay abreast of changes ... on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development… more
- Bausch Health (Bridgewater, NJ)
- … regulatory considerations that may impact business. + Works closely with the Regulatory Affairs prescription drug labeling group regarding package insert ... regulatory agency guidance. **KEY ACTIVITIES/RESPONSIBILITIES:** + Manages or represents Regulatory Affairs on the promotional review committees for… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Senior Director supporting...development, global registration, achievement and maintenance of desired regional labeling , and effective regulatory agency interactions +… more
- Bristol Myers Squibb (Madison, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The role of Associate Director of US Commercial Regulatory Affairs requires the ... Labeling Branch advisory submissions and sub part e/h submissions. + Ensure full regulatory compliance of all promotions with approved labeling and /or FDA… more
- Bausch Health (Philadelphia, PA)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to ... approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency...and the ability to see business drivers outside of regulatory affairs + Working knowledge of the… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Apr 26, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... a difference, and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to manage and help… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the ... prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a...AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director , Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... project updates, risks and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory Affairs and Senior… more
- Sanofi Group (Bridgewater, NJ)
- …and Capabilities** + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for ... The Associate Director RA serves as the regulatory ...leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising… more
- Astrix Technology (Gaithersburg, MD)
- Regulatory Labeling Director (BioPharma) Regulatory Affairs Gaithersburg, MD, US Pay Rate Low: 60 | Pay Rate High: 64 + Added - 11/04/2024 Apply for ... + Provides labelling expertise for assigned products regarding language, placement and regulatory content detail **Qualifications:** + Labeling expertise in Core… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
