- 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 ... filing in US and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares and directs global … more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director Regulatory Affairs , Chemistry, Manufacturing ... marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research &… more
- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will ... CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine… 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 ... are technically complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and ability to work… more
- Novo Nordisk (Plainsboro, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions +… more
- Sumitomo Pharma (Columbus, OH)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs ** . The ... Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she is expected to provide regulatory support from proof of… more
- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - US New ... is helpful. + Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience with 510k / PMA / DeNovo submissions… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will ... mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is seeking a dedicated and innovative Director /Senior Associate Director , Global Regulatory Affairs CMC for Chemical products to join ... to the continuous improvement of processes and standards within Regulatory Affairs . If you have a strong...Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate Director … 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 of ... PA office. This is a hybrid position. You will report to the Director of Global Regulatory Affairs . **Responsibilities:** You are a member of a Regional… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, ... and influencing the field as applicable. **How you will contribute:** + The Associate Director will be responsible for increasingly complex or multiple projects.… 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 ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , RA CMC Post Approval Change Dossier Manager ... experience + Preferred: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing,… more
- Abbott (Lake Forest, IL)
- …and work experience. + **Minimum 10 years** of progressive work experience in regulatory affairs or a related discipline in the in vitro diagnostics/medical ... experience in medical devices and thorough knowledge of clinical research and/or regulatory affairs preferred. Academic or in-house courses in leadership,… more
- Bristol Myers Squibb (Princeton, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Merck (Lower Gwynedd, PA)
- …Us:** The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and… 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 ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director , Analytical Regulatory Sciences, Systems & ... a site based position located in Foster City, CA_** The Associate Director , Analytical Regulatory Science, collaborates with product development,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …reflect Boehringer Ingelheim's high regard for our employees. The Director /Senior Associate Director , Medical Affairs Strategy Team Member serves as ... clinical development efforts where applicable. The Director /Senior Associate Director , Medical Affairs Strategy...related industry. + -1+ years of experience in Medical Affairs , Clinical Trials, Regulatory , or related area… more