- AbbVie (North Chicago, 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
- 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
- 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
- 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
- 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
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Mar 28, 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
- 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
- AbbVie (Irvine, CA)
- …Follow Allergan Aesthetics on LinkedIn. Job Description Purpose: The Director Regulatory Affairs Pharmaceuticals, Facial Aesthetics, ... secure and maintain market approval for product(s) and representing Regulatory Affairs on R&D Project teams. Leads.... Acts independently under the direction of a Sr Director . . May participate in or lead regulatory… more
- Merck (North Wales, PA)
- …review divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and ... **Job Description** Reports to the Director /Senior Director in the Office of...standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to… more
- Takeda Pharmaceuticals (Columbus, OH)
- …applicable regulatory requirements. You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will...independent skills in the area of regulatory affairs such as understanding broad concepts within labeling… more
- Boehringer Ingelheim (Ridgefield, CT)
- …to five (3-5) years of experience in the pharmaceutical industry with experience in Regulatory Affairs . + Specific experience in regulatory advertising and ... labeling . Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on promotional communications. Review scientific exchange communications… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …for the clinical research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the ... Job Title Senior Director , Clinical Development & Medical Affairs ...Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device… more