- Daiichi Sankyo, Inc. (Bernards, 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...Acts as point of contact for cross-functional teams on RA labeling issues. Based on timelines or… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... advance our pipeline and drive our strategic priorities.The Director , Principal Scientist - Regulatory Affairs...to approval by global regulatory agencies.Reports to Associate Vice President, Executive Director , or Senior… more
- Merck & Co. (Rahway, NJ)
- …DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... our strategic priorities.Summary, Focus and PurposeThe Senior Principal Scientist - Regulatory Affairs Liaison is responsible for development and implementation… more
- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... review divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs ( RA ) CMC project representative to the CMC ... higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting company… 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...Acts as point of contact for cross-functional teams on RA labeling issues. Based on timelines or… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Represents RA Ad/Promo at Regulatory Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance. ... Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion ( RA Ad/Promo) is... Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a… more
- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs...approve labeling to ensure compliance. + Represent regulatory affairs in product recall and recall… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to ... your skills and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves… more
- Merck (Boston, MA)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs...by global regulatory agencies. + Reports to Associate Vice President, Executive Director , or Senior… more
- Merck (Boston, MA)
- …We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... **Summary, Focus and Purpose** The Senior Principal Scientist | Regulatory Affairs Liaison is responsible for development...external to GRACS. **Key Functions** + Reports to Executive Director or Associate Vice President, General Medicine… more
- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - US New ... process to ensure submission approval. + Review and approve labeling to ensure compliance. + Monitor emerging issues and...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience… more
- Merck (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... review divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and… more
- American Heart Association (Washington, DC)
- …your career. The **American Heart Association** has a phenomenal opportunity for an ** Associate ** ** Regulatory Affairs Manager** with our Federal Advocacy ... (hybrid work arrangements available. Under the direction of the Director , Federal Regulatory Affairs , you...of Agriculture (USDA). Core topics would include nutrition, food labeling , and prevention, with the opportunity to assist on… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs ( RA ) CMC project representative to the CMC ... manager. + ** Regulatory Knowledge:** Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting company… more
- System One (Florham Park, NJ)
- …regions, and provide insights to the Senior Director and Associate Director . + Contribute to managing regulatory risks and opportunities related to QOL ... Senior Manager, Regulatory Affairs (BRANDED PRODUCTS) Must be...(QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the best of my knowledge. **Job Description** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review out of our Lexington, MA or ... of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and… more
- AbbVie (Mettawa, IL)
- …with HEOR Strategy and other functions (eg, Clinical Development & Operations, Regulatory , Commercial). The Associate Director , Patient-Centered Outcomes ... , Medical Affairs , and the Commercial organization. In addition, the Associate Director will support collaborations with external partners (eg, industry… more
- Lilly (IN)
- …communities through philanthropy and volunteerism. ** ** **Position Summary:** The Associate Director , Clinical Supply Management has responsibility for the ... with team members across functions including but not limited to clinical operations, CMC, regulatory affairs , and QA. + Working knowledge of cGMP's (CFR/ICH) and… more
- WuXi AppTec (Natick, MA)
- …in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC dossiers to ... any scale. Beyond chemistry, we offer formulation development, drug product manufacturing, labeling and distribution services in a variety of injectable dosage forms… more
