- Arthrex (Naples, FL)
- … Regulatory Affairs for our Global Headquarters in Naples, FL. The International Regulatory Affairs Senior Specialist will advance Arthrex's ... in internal or external audits. Develop and/or conduct employee training for International Regulatory Affairs . Education and Experience: Bachelor's degree… more
- Takeda Pharmaceutical (Boston, MA)
- …order to bring life-changing therapies to patients worldwide.The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is ... to prescription medicine promotion.How you will contribute:As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional ... (fast track, RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in quality and compliance.Evaluate risks impacting GxP compliance within Medical Affairs , driving ongoing improvements to meet regulatory requirements and ... for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in...regulatory requirements particularly in the areas of Medical Affairs and Clinical Development; Must have a strong understanding… more
- Merck & Co. (Rahway, NJ)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Insmed Incorporated (NJ)
- …Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial ... each other, and for the future of science, we're in. Are you?About the Role:The Senior Director, Head of US HCP Marketing for our TPIP program in Pulmonary Arterial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... Experience: Demonstrated track record of success working on multidisciplinary, international pharmaceutical development teamsExperience with CDx regulatory … more
- Insmed Incorporated (NJ)
- …Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial ... other, and for the future of science, we're in. Are you?About the Role:The Senior Director, Head of US HCP Marketing for our brensocatib program in HS (hidradenitis… more
- Eisai, Inc (Memphis, TN)
- …of MSLs in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively ... with Medical Affairs and Clinical Development teams for support of clinical...of the FDA, OIG, HIPPA, PhRMA, GCP and other international regulatory /ethical guidelines relevant to the pharmaceutical… more
- Medtronic (Irvine, CA)
- …innovation in a more connected, compassionate world. **A Day in the Life** ** SENIOR REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR** _Onsite Position Located ... with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining … more
- Danaher Corporation (Boston, MA)
- …Business Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will...internal procedures are updated to reflect evolving US and international regulations. + Assess the impacts of relevant drug… more
- Abbott (Pleasanton, CA)
- …from diagnosis to monitoring and treatment. **The Opportunity** We are recruiting for a ** Senior Regulatory Affairs Specialist** to join our team on-site in ... products. + Prepares robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and organizational objectives.… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite ... also have access to: + Career development with an international company where you can grow the career you...Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is… more
- West Pharmaceutical Services (Exton, PA)
- Senior Regulatory Affairs Specialist Requisition ID: 71673 Date: Oct 6, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs ... and planet through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs , Medical is responsible for influencing department … more
- Stryker (Redmond, WA)
- We are currently seeking a ** Senior Regulatory Affairs Specialist** to join our **Medical** **Division** to be based **Hybrid** in **Redmond, Washington.** ... As part of the Medical Regulatory Affairs team, you will work with... classification and jurisdiction. + Determine requirements (local, national, international ) and options for regulatory submission, approval… more
- BeOne Medicines (San Mateo, CA)
- …or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline + and ... medical affairs , and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical … more
- Abbott (Plymouth, MN)
- …get on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Senior Regulatory Affairs Specialist** to join our team on-site in ... guidance and expertise on complex worldwide strategies with the help of international regulatory affiliates. + Compile, prepare, review and submit medical… more
- Parexel (Nashville, TN)
- **Join Parexel as a Regulatory Affairs Strategy Lead** Are you a strategic thinker with a passion for navigating the complex world of global regulatory ... plans? If so, we'd love to connect. We're seeking Regulatory Affairs Strategy Leads who will be...biologics * Deep knowledge of FDA, ICH, and global regulatory frameworks * Experience with international clinical… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and become your best self. Become a **maker of possible** with us. The Sr. Director, Regulatory Affairs is the ranking Regulatory Affairs leader for the ... regulatory leadership for programs in the domestic and international space + Provides strategic guidance to ensure alignment...business partners, provides input into the budget process for Regulatory Affairs + Represents the Platform in… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product… more