- 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
- Ascendis Pharma (Palo Alto, CA)
- 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
- 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
- J&J Family of Companies (Horsham, PA)
- …Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing labeling ... Associate Director , Global Labeling Product Leader -...regulatory guidelines and their applications for guidance for labeling . + Experience leading project teams within a matrix… 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
- 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
- J&J Family of Companies (Trenton, NJ)
- Director , Global Regulatory Leader (GRL) (1 of 2)...and OUS markets. + Serve as a member of the Labeling Working Group to create or update the CCDS and ... Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of...they are doing in early/late development and knowledge of labeling aspects + Impact and Influence: Able to persuade,… 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
- J&J Family of Companies (Raritan, NJ)
- Senior Director , Global Regulatory Leader, CAR-T Therapy - 2406186120W **Description** Johnson & Johnson is currently seeking a Senior Director , Global ... have a positive impact on their communities. The Senior Director , Global Regulatory Leader, CAR-T Therapy will...Development Team, Global Dossier Team, Clinical Team, and the Labeling Working Group. + Ensure that regulatory … more
- Abbott (Abbott Park, IL)
- …data is maintained in electronic systems. + Depending on specific role, the Associate Director Regulatory Affairs may be involved in various regulatory ... medicines. Our 114,000 colleagues serve people in more than 160 countries. **Associate Director of Regulatory Affairs** **About Abbott** Abbott is a global… more
- Novo Nordisk (Princeton, NJ)
- …a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions +… 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 ... as Regulatory Affairs (RA) team member in projects as well...technical input for Freedom of Information Summary and product labeling for assigned projects. + Work in project teams… more