- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is seeking a dedicated and innovative Director /Senior Associate Director , Global Regulatory Affairs CMC for Chemical products ... CMC Director or Senior Associate Director has responsibility for the strategic global ...Projects requiring extraordinary regulatory expertise within Group Global CMC Regulatory Affairs . +… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will ... define, develop and lead global strategies to maximize global ...field as applicable. **How you will contribute:** + The Associate Director will be responsible for increasingly… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Lead, GI & Inflammation ... where you will define, develop, and lead global strategies to maximize global ...field as applicable. **How you will contribute:** + The Associate Director will be responsible for complex… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Associate Director , Global Regulatory Affairs ? The job is located in our King ... is a hybrid position. You will report to the Director of Global Regulatory Affairs . **Responsibilities:** You are a member of a Regional Therapeutic Area… more
- Takeda Pharmaceuticals (Columbus, OH)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Patient Safety Clinical Operations in Cambridge, ... Liaise with and advise study teams including Clinical Science, Data Management, Regulatory Affairs , and other functional areas locally/globally on matters… more
- Takeda Pharmaceuticals (Columbus, OH)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning ... - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global … more
- Takeda Pharmaceuticals (Columbus, OH)
- …employment application is true to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is responsible for ... to the world. **How you will contribute:** + The Associate Director , GRA Labeling Compliance, is responsible...global and local labeling compliance and quality within Global Regulatory Affairs . + Partners… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- BeiGene (Emeryville, CA)
- **General Description:** The incumbent will: + Lead the activities of the Global Regulatory Affairs SOP Committee regarding life-cycle management of ... Global Regulatory Affairs SOP compliance. To include but not limited to: + Chair the SOP Review Committee to ensure requirements are followed per applicable… more
- Teleflex (Morrisville, NC)
- Associate Global Medical Safety Director (Part Time/Remote US) **Date:** Dec 26, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected ... global Teleflex portfolio reporting directly to the Global Medical Safety Director . As part of...clinicians and their patients. **Principal Responsibilities** Quality Assurance and Regulatory Affairs * Provide subject matter expertise… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- Sumitomo Pharma (Columbus, OH)
- … Affairs ** . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected...pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs + Include the qualifications preferred… more
- AbbVie (Mettawa, IL)
- …key opinion leaders, research organizations, patient advocacy groups). The Associate Director represents HEOR at global regulatory and payer / ... with HEOR Strategy and other functions (eg, Clinical Development & Operations, Regulatory , Commercial). The Associate Director , Patient-Centered Outcomes… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Advertising and Promotion ( RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic ... partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful ... affairs management, the incumbent independently prepares and directs global regulatory affairs activities and provides regulatory guidance during… more
- Ascendis Pharma (Palo Alto, CA)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for ... of current global and regional trends in regulatory affairs and ability to assess the...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will ... Abbott is a global healthcare leader that helps people live more...Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs… more
- Lilly (Indianapolis, IN)
- …intelligence tools **Additional Information:** + This role will report to the Associate Vice President, ExploR&D, Regulatory Affairs , Medical Writing, ... effective decision-making related to molecule development. + Consult on global regulatory strategy, advise on IND/CTA content...college or university + At least 5 years of regulatory affairs experience with research-based drug development,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... of US regulatory submissions and provide US regulatory support across all global projects; meet...read journals, newsletters, scientific papers; research the answers to RA questions. **Qualifications** : Successful candidates will be able… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director , Analytical Regulatory Sciences, Systems & ... site based position located in Foster City, CA_** The Associate Director , Analytical Regulatory Science,... RA Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory… more
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