- Merck (North Wales, PA)
- … Director position. Under direction from a Director , the Associate Principal Scientist is responsible for implementing regulatory strategies for our ... **Job Description** This Associate Principal Scientist position is equivalent to an...Scientist will lead the development and the implementation of regulatory strategies for their assigned projects and provide mentoring… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You will ... in collaboration with their regional counterparts. + As the Associate Director , you will be responsible for...are effectively implemented and maintained in line with changing regulatory and business needs. + Ensures project … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director Regulatory Affairs...focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in ... regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...Own the preparation of major clinical submissions required for regulatory approval. + Work with project teams… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** We are seeking an Associate Director , Regulatory Affairs CMC candidate to sit at our ... Foster City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at...risk assessment exercises. + Coordinates and facilitates development of Regulatory CMC strategies with development and commercial project… more
- Abbott (St. Paul, MN)
- …vessel closure devices, peripheral stents, and atherectomy devices. **The Opportunity** This ** Associate Director Regulatory Affairs** will work on-site at ... Vascular Division. As a manager, the function of an Associate Director Regulatory Affairs is...produce and market new products. + Provides guidance on regulatory requirements and strategies to product development project… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC...annual licenses, registrations, listings and patent information. + Create project plans and timelines. + Lead cross functional groups… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible ... cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs. Responsibilities and Duties...Affairs. Responsibilities and Duties + Act as the Global Regulatory Lead on multi-disciplinary project teams and… more
- AbbVie (Branchburg, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs US Advertising and ... cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global… more
- J&J Family of Companies (Spring House, PA)
- …and if approved by the Company. **We are searching for the best talent for Associate Director , Regulatory Medical Writing - Oncology.** **Purpose:** + Able ... compound independently. + Leads in setting functional tactics/strategy. + Leads project -level strategy (eg, submission team, global program team, clinical team). +… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory /Scientific Affairs and Quality! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA) teams by...Project Verification. + Stay abreast of the changing regulatory , legal, quality and competitive landscape. + Assess and… more
- GRAIL (Washington, DC)
- …technology, and healthcare companies. For more information, please visit grail.com . The Associate Director of Global Regulatory Affairs & Safety serves ... GRAIL's UK Responsible Person (UKRP). Interfaces with MHRA and other International regulatory agencies, Notified Bodies, and external consultants as needed, on IVD… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …site and Friday remotely on a weekly basis. **Summary of Job Responsibilities** The Associate Director of Regulatory Affairs will provide regulatory ... is not limited to the development and implementation of regulatory strategies for new product submissions, project ...of regulatory strategies for new product submissions, project management for regulatory affairs submissions, handling… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Associate Director of Regulatory Affairs, you will lead regulatory activities for new product development, labeling ... changes, promotional requests, and other regulatory submissions in both Canada and the United States....Strong analytical skills and attention to detail. + Demonstrated project management skills. Salary ranges have been implemented to… more
- Bristol Myers Squibb (Princeton, NJ)
- …Competencies** + Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance. ... and Drug sponsor. + Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry. Experience… more
- Gilead Sciences, Inc. (Foster City, CA)
- …or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional ... together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds,...direct reports. + Provides matrix management and leadership to project teams. + Provides accurate and thorough input and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …on new marketing concepts, messaging, and campaigns. + Represents RA Ad/Promo at Regulatory Project Team meetings. + Represents RA Ad/Promo at labeling meetings ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **OBJECTIVE / PURPOSE** + Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in various stages ... of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to...and/or leads agency meetings on CMC topics + Ensures project team colleagues, line management, and key stakeholders are… more
- United Therapeutics (Eden Prairie, MN)
- …We are looking for a regular strategist who will advise on regulatory pathways, managing documentation and timelines, and supporting the preparation and execution ... of regulatory submissions for our whole tissue engineering program. Are...a related area of study + 8+ years of project or people management experience + Must have written… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Statistical Project Leader - Associate Director **Location:** Morristown, NJ, Cambridge, MA **About the Job** Are you ready to shape the future ... accelerate progress. Join our **Biostatistics Immunology & Inflammation team as Statistical Project Leader ( Associate Director )** and you'll provide… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
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