- 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
- 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. (Rahway, NJ)
- …CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling ... Therapeutic Area, and under the supervision of the Global Labeling Strategic Director , the GLL is responsible... labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of… 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 (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
- Gilead Sciences, Inc. (Foster City, CA)
- …make a direct impact. Join Gilead and help create possible, together. **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
- Astrix Technology (Countryside, IL)
- Director Regulatory Labeling Regulatory Affairs Countryside, IL, US + Added - 21/03/2024 Apply for Job _The Regulatory Labeling Manager ... Engineering. + A minimum of 3 years of experience in regulatory affairs including FIFRA, Hazardous Material Regulations, Dangerous Goods, and familiarity with… more
- Astellas Pharma (Northbrook, IL)
- …and affiliates members). The position reports to the Executive Director , CCDS and Labeling , Regulatory Affairs . The individual may have direct reports at ... work are encouraged to apply. **Purpose and Scope:** The Director ROW Labeling Lead will report to...higher degree. + Relevant experience in Regulatory Affairs in the area of labeling development… 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
- Boehringer Ingelheim (Ridgefield, CT)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , US Product CMC Regulatory Affairs is responsible for ... post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs...Review Team (PLRT) and in collaboration with US RA Labeling Content, provide regulatory support during Annual,… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- **Job Description Summary** Reporting to BD Biosciences (BDB) Sr. Director of Regulatory Affairs , and supporting the clinical platform leader of BDB, the ... Director of Regulatory Affairs (RA)...Director of Regulatory Affairs (RA) provides pre-market ...Global Product Development System (GPDS) + Serves as a regulatory expert for labeling and promotional materials… 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
- Lundbeck (Deerfield, IL)
- …the greater United States, preferably East Coast or Midwest **SUMMARY:** The Senior Director , Regulatory Affairs Global Strategic Labelling, oversees the ... Senior Director US Regulatory Global Strategic Labeling - Remote...development programs. + Trains, develops, and manages an effective regulatory affairs team on key labelling requirements,… more
- Boehringer Ingelheim (St. Joseph, MO)
- …programs reflect Boehringer Ingelheim's high regard for our employees. As the Manager/Associate Director , Regulatory Affairs Pharma Safety & Efficacy you ... will: Act as Regulatory Affairs (RA) team member in projects...technical input for Freedom of Information Summary and product labeling for assigned projects. + Work in project teams… more
- J&J Family of Companies (Washington, DC)
- Associate Director , Regulatory Affairs - 2406166277W...and Canada. + Serve as a member of the Labeling Working Group to create or update the Company Core ... Johnson's Family of Companies, is recruiting for an Associate Director , Regulatory Affairs . This position...maintain knowledge of competitors in the therapeutic area, including labeling aspects and what they are doing in early/late… more
- Bausch + Lomb (Bridgewater, NJ)
- …marketing labeling changes. + Responsible for post approval lifecycle management of labeling . + Coordinate with Regulatory Affairs members and other ... approvals. + Knowledge of pharmaceutical, consumer or medical device industry regulatory affairs discipline throughout the product lifecycle including… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology** ... you will do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Oncology Therapeutic Area.… 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