- Eisai, Inc (Philadelphia, PA)
- …vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the ... a difference. If this is your profile, we want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible for leading,… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- Job Summary The Associate Director , Global Product Quality - GMP Process is responsible for enabling the optimization and harmonization of key GMP quality ... Actions (CAPA), Deviations, and Change Control , ensuring compliance with global regulatory requirements and internal standards. The successful candidate… more
- Insmed Incorporated (NJ)
- …us expand what's possible for patients with serious diseases. Reporting to the Associate Director , Regulatory Affairs , Tactical Implementation, you'll ... in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs , Tactical Implementation, on the ...assigned programs and market. Under the guidance of the Associate Director , you will ensure high-quality, timely,… more
- Organon & Co. (Plymouth Meeting, PA)
- Job Description **The Position ** Reporting to the Director in Organon Regulatory CMC, the Associate Principal Scientist is responsible for developing and ... strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation… more
- Insmed Incorporated (NJ)
- …the operational execution of the company's Global We're looking for an Associate Director , Medical Review Committee Operations, on the Medical Review team to ... future of science, we're in. Are you?About the Role:The Associate Director , Medical Review Committee (MRC) Operations...degree along with 5+ years of experience in Medical Affairs , Regulatory Affairs , or related… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …and business development programs. Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... The Associate Director of Regulatory ...Job Description Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new… more
- Takeda Pharmaceuticals (Lexington, MA)
- …clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial functions Coordinate interdepartmental initiatives ... is true to the best of my knowledge. Job Description About the Role: The Associate Director of Device Clinical Development (DCD) in the Drug Product and Device… more
- Insmed Incorporated (NJ)
- …and QC of regulatory documents prior to submission.Ensure adherence to global regulatory authority technical requirements (FDA, EMA, Health Canada, MHRA, ... submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs , CMC, Clinical, Quality) to facilitate document… more
- Sumitomo Pharma (St. Paul, MN)
- …Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director , Clinical Business Operations, the specialist ensures accountable ... Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations...validation is maintained. Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with … more
- J&J Family of Companies (Raritan, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Regulatory Affairs Diagnostics. This position is ... We invite candidates from any location to apply. The Associate Director , Global Regulatory Affairs Diagnostics will provide an opportunity to… more
- Takeda Pharmaceuticals (Boston, MA)
- …to transformative medicines and make a lasting impact on patients worldwide. Join Takeda as Associate Director , Global Regulatory Lead Oncology where you ... will be part of the global regulatory team. As Associate Director ,...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you will… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning ... - Oncology TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global … more
- Otsuka America Pharmaceutical Inc. (Little Rock, AR)
- **Job Summary** The Associate Director , Global Product Quality - GMP Process is responsible for enabling the optimization and harmonization of key GMP ... Actions (CAPA), Deviations, and Change Control** , ensuring compliance with global regulatory requirements and internal standards. The successful candidate… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Position Summary:** **The Associate Director - Global Quality Management Review Lead will drive ... liaison between Global Quality and business units (eg, regulatory affairs , manufacturing, IT) to ensure metric relevance and adoption.** **Enable clear… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda drug product manufacturing ... GMSci DP/PKG** **Location: Cambridge, MA** **About the role:** As a Process Scientist ( Associate Director ) - Global Manufacturing Science GMSci Drug Product… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards ... + Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of … more
- Teva Pharmaceuticals (West Chester, PA)
- …and new people to make a difference with. **The opportunity** The Associate Director , Global Regulatory Affairs , will be responsible for providing ... Associate Director , Regulatory Affairs Date:...respiratory, dermatology, gastroenterology, or other therapeutic areas within the Global Regulatory Affairs Innovative Medicines… more
- Takeda Pharmaceuticals (Boston, MA)
- …Payer Marketing and Market Access, Global Evidence and Outcomes, Medica Affairs , Clinical Development, Regulatory Affairs , Biostatistics, Global ... Market Access, Pricing, Advocacy, Biostatistics, Global Evidence and Outcomes, Medical Affairs , Clinical Science, Legal, Regulatory + OBU 10, EUCAN, GEM… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …day and improving the lives of patients for generations to come. As an Associate Director , Global Regulatory Affairs , you will act as the Regional ... Affairs and may serve as Regional Regulatory Lead or Global Regulatory ...current global and regional trends in biopharmaceutical regulatory affairs . Proven effectiveness applying this knowledge… more
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