- Takeda Pharmaceuticals (Boston, MA)
- …life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development ... and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI… more
- Stryker (Redmond, WA)
- …+ Evaluate product classification and jurisdiction, and determine appropriate regulatory pathways and compliance requirements (local, national, international) ... and claims, while maintaining current product registrations + Assess proposed pre- clinical , clinical , and manufacturing changesfor regulatory impact… more
- Bausch + Lomb (Madison, WI)
- …reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance , regulatory intelligence and change ... US and/or Canada + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical...to product development teams and give guidance on potential regulatory compliance issues + Point of contact… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and ... a Manager, of Advertising and Promotion to join our Regulatory Affairs team!! **In this role, a typical day...commercial team's objectives, while maintaining the necessary state of compliance and corporate integrity. **This role might be for… more
- Edwards Lifesciences (Irvine, CA)
- …procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance , consistency, and accuracy + Provide ... content product and process changes, and product documentation to assure regulatory requirements compliance , consistency, and accuracy **What you'll need… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject… more
- UTMB Health (Galveston, TX)
- …procedures. + Provide internal and external communications, scientific expertise, and regulatory compliance expertise; able to interact and communicate with ... communication and interpersonal skills. + Knowledge of and ability to interpret regulatory requirements and perform duties in compliance with those requirements.… more
- Ascendis Pharma (Princeton, NJ)
- …medical, payor, corporate, and other non-promotional materials to assess for regulatory compliance with the applicable regulations, guidance documents, and ... working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs, Advertising and Promotion will be an internal expert on US FDA… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and ... (BLAs) and Marketing Authorization Applications (MAAs). They will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying… more
- J&J Family of Companies (Irvine, CA)
- …of regulatory information to the product development, marketing, and clinical groups. + Performs Copy Review for internal and external facing documentation ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more