- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs - Neurology is from :272,200-357,300Under current… more
- Cytokinetics (South San Francisco, CA)
- …contractility. Job purpose Cytokinetics is seeking an experienced and highly motivated Senior Director , Regulatory Affairs to join the Global Regulatory ... the latest regulatory requirements and industry standards are met. The Senior Director , Regulatory Affairs will lead the Global Regulatory Team for… more
- Revolution Medicines (Redwood City, CA)
- …cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Associate Director of Regulatory Affairs will independently represent ... to ensure successful regulatory outcomes. Demonstrate leadership within the regulatory affairs department and cross-functionally to help develop, implement,… more
- Sanofi (Morristown, NJ)
- Job Title: Director , Global Regulatory Affairs - Global Labeling Strategy Location : Morristown, NJ or Cambridge, MA (Hybrid) About the Job Are you ready to ... skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy is responsible for… more
- Public Health Trust of Dade Co (Miami, FL)
- …most skilled and highly regarded multidisciplinary team of healthcare professionals. Summary The Assistant Director of Regulatory Affairs is a member of the ... of care and services. Provide organizational support to the Corporate Director of Regulatory Affairs to ensure effective communication and oversight of… more
- Genmab A/S (Princeton, NJ)
- …fit? Then we would love to have you join us! Genmab is looking for an Associate Director , Global Regulatory Affairs , Regulatory Strategy to be a part of ... our Global Regulatory Affairs organization. In this role, you will work in close collaboration with the Global Regulatory Lead on a compound in late-stage… more
- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Merck & Co. (Rahway, NJ)
- …Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement ... Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Eli Lilly and Company (Indianapolis, IN)
- …over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC technical ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing...knowledge and regulatory science expertise to drive regulatory CMC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- System One Holdings, LLC (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves : Must be ... IND/NDA development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in developing and executing regulatory… more
- Cedent (Cambridge, MA)
- …years of experience in the pharmaceutical/biotechnology industry, with at least 5 years in Regulatory Affairs . Experience in key areas of regulatory ... Summary: Reporting to the Chief Medical Officer and collaborating with external regulatory advisors, this role is responsible for developing and executing … more
- Omega Medical Imaging LLC (Sanford, FL)
- …experienced leader to innovate and manage our Quality Management System (QMS) and regulatory activities. In this on-site role (no remote), you will ensure full ... Key Responsibilities: Lead and continuously improve Omega's QMS to ensure regulatory compliance and product excellence. Guide 510(k) submissions, CE marking, and… more
- Central Garden & Pet (Dallas, TX)
- … Affairs (FSRA) Manager to join our team! This position reports to the Sr. Director , FDA Regulatory Affairs & Food Safety and will support all applicable ... compliance. The position will also center on supporting the Sr. Director , FDA Regulatory Affairs & Food Safety while assuring FDA, other federal,… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the ... International). Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Medical Affairs Training and Education is from… more
- Novo Nordisk Inc. (WA)
- …locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director , Policy. Other internal relationships include a dotted ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare...in Plainsboro, NJ or Washington, DC. The Position The Director - US Tax, Trade, IP works on complex… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …any time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Support representatives in answering physicians questions Works with Executive Director to define therapeutic area disease and treatment concepts… more
- Johnson and Johnson (Raynham, MA)
- …SUPPORT Work with cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics & Market Access (HEMA) ... of America Job Description: Johnson and Johnson is currently seeking a Medical Director , Medical Affairs , Orthopedics (Spine) located in Raynham, MA. About… more
- Pivotal Solutions (Boston, MA)
- …with company objectives. Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs , and Marketing, to ensure cohesive medical ... Job Description Position Overview: The Sr. Director of Medical Affairs plays a...ensure the safety of products. Ensure that all Medical Affairs activities comply with regulatory and industry… more
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