- Lundbeck (Deerfield, IL)
- Senior Director US Regulatory Global Strategic Labeling - Remote opportunity Requisition ID: 5047 Location: Deerfield, Illinois, US Do you want to join a ... greater United States, preferably East Coast or Midwest **SUMMARY:** The Senior Director , Regulatory Affairs Global Strategic Labelling, oversees the process… more
- Endo International (Woodcliff Lake, NJ)
- …directly to the Regulatory Affairs Labeling Director . The Regulatory Labeling Senior Associate will be responsible for the development/revision ... for Labeling Updates (SLC, RLD, FDA Letters) for all Endo sites. The Regulatory Labeling Senior Associate will be expected to work in an environment that… more
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director Regulatory Affairs, Strategic Global Labeling , combines the ... Director of Strategic Labeling , establishes labeling policy compliant with changing regulatory environment....Presents process, strategy, and product labeling at Senior level meetings (Global Regulatory Forum (GRF),… more
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Regulatory Affairs, Strategic Global Labeling - Combination ... guidelines, standards, etc. + Experience developing and implementing successful global regulatory labeling strategies. + Experience with InDesign a plus.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … agencies. You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the oncology therapeutic ... + Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the...and career interests. Position will be filled as a Senior Manager or Associate Director , based on… more
- Bristol Myers Squibb (Princeton, NJ)
- …externally, contributing to cross-functional initiatives and identifies opportunities to influence regulatory policy and climate with respect to labeling content ... + Understands and interprets complex scientific issues as related to regulatory requirements and labeling strategy. Partners with key internal and external… more
- Kelly Services (Gaithersburg, MD)
- Description: The Labelling Strategy Associate Director provides regulatory labelling expertise, typically for more complex drug projects, to the Global ... Regulatory Submission Team (GRST)/Global Regulatory Execution Team...Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous… 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 the ... post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts...Review Team (PLRT) and in collaboration with US RA Labeling Content, provide regulatory support during Annual,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the ... marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs,... labeling and with all applicable regulations. TheSenior Director , Commercial Regulatory Affairs will stay abreast… 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
- 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: ... making a difference, and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to manage and… more
- BeiGene (San Mateo, CA)
- **General Description** + The Senior Director , Global Regulatory Lead will be responsible for developing, implementing, and advising on global regulatory ... of key regulatory issues and to expedite approvals of product and labeling changes. + Maintains awareness of global regulatory environment and assesses… more
- CSL Behring (King Of Prussia, PA)
- …will provide support to CSL's Executive Director , Global Labeling & Global Regulatory CTA and senior team members. You will have the ability to leverage ... technology for efficient processes. This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid **The Role:** + Calendar Management: coordinates and ensures efficiency in scheduling "gatekeeper" and "gateway" role, works… more
- Merck (North Wales, PA)
- **Job Description** Reports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is ... review divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and… more
- BeiGene (San Mateo, CA)
- **General Description:** The Senior Medical Director serves as the Product Safety Physician for complex strategically important developmental programs and ... review topics/ CSC agenda items + Leads communication of recommendations to labeling group/other stakeholders + Actively participates in meetings as required in… 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 Rare ... promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and… more
- AbbVie (North Chicago, IL)
- …strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director , Global Regulatory Lead, is responsible for developing and… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …oversight of our clinical development programs, ensuring they meet the highest scientific and regulatory standards. The Senior Director will also play a key ... Job Title Senior Director , Clinical Development & Medical...issues related to development compounds or marketed products including labeling discussions/updates, interactions with Regulatory Agencies, and… more
- Boehringer Ingelheim (St. Joseph, MO)
- …reflect Boehringer Ingelheim's high regard for our employees. As the Manager/Associate Director , Regulatory Affairs Pharma Safety & Efficacy you will: Act ... technical input for Freedom of Information Summary and product labeling for assigned projects. + Work in project teams...Profile and Quality Target Profile. + Works with more senior RA team members to provide consistent regulatory… more
- AbbVie (Irvine, CA)
- …Follow Allergan Aesthetics on LinkedIn. Job Description Purpose: The Director Regulatory Affairs Pharmaceuticals, Facial Aesthetics, is responsible ... . Acts independently under the direction of a Sr Director . . May participate in or lead regulatory...functional management, including RDLT and Commercial Leadership of issues, labeling outcomes, approval or other risks and mitigations. Provides… more