- 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....labeling environment. + Under the direction of the Director , Global Labeling , provides regulatory … more
- AbbVie (Lake Bluff, 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
- 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 Job ... + Provides labelling expertise for assigned products regarding language, placement and regulatory content detail **Qualifications:** + Labeling expertise in Core… 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)
- … 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...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)
- …around rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides ... strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of… more
- Takeda Pharmaceuticals (Columbus, OH)
- …labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling requirements are met for assigned products. **How you will ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will...regulatory requirements. You will serve as the regulatory expert for … 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...(Monday-Friday), 8 hours per day. Remote position. Top priorities: Labeling expertise in Core Data Sheet, EU/US labelling experience,… more
- Merck (North Wales, PA)
- **Job Description** **Position Description:** **Legal Director (FDA promotion/ Labeling Drugs & Vaccines)** The position provides legal support to the Human ... 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
- 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 in the ... on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the development and… more
- Bausch Health (Bridgewater, NJ)
- …in the review, approval and monitoring of prescription drug advertising and promotional labeling pieces. The Director is responsible for ensuring the pieces are ... at FDA's Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulatory considerations that may impact… 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
- Bausch Health (Philadelphia, PA)
- …reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. **KEY ... to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine 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 ability ... submissions and sub part e/h submissions. + Ensure full regulatory compliance of all promotions with approved labeling... regulatory compliance of all promotions with approved labeling and /or FDA guidances. + Ensure regulatory… more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning ... + Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials. + Develops solutions… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology** ... will do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Senior Director supporting products in the Oncology Therapeutic Area.… 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
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global Strategic Labelling - Remote Opportunity Requisition ID: 5211 Location: Deerfield, Illinois, US Do you want to join a team where ... - Open to candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling, oversees the process… more
- AbbVie (Boston, MA)
- …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