- 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
- 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
- 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
- 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
- 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
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at ... in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine knowledge of scientific,… more
- 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 :272,200-357,300 Under current… more
- Sutro Biopharma (South San Francisco, CA)
- Description Sutro Biopharma, Inc. is looking for a Director , Regulatory Affairs Medical Writer who will provide leadership in development and execution of ... INDs/CTAs, and technical reports, as necessary. Works with Project Management and Regulatory Affairs functions to establish appropriate timelines and identify… more
- Kyowa Kirin North America (Princeton, NJ)
- …offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director , Regulatory Affairs , Advertising and Promotion Compliance ... for an assigned product to ensure compliance with US regulatory requirements. In addition, the associate director ...US regulatory requirements. In addition, the associate director will be responsible for supporting preparation of FDA… 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
- Olema Oncology (San Francisco, CA)
- …As the Director , Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you will lead the development of labeling ... end-to-end label implementation. This role will work closely internally with Regulatory Affairs , Clinical Development, Clinical Supply (CS), Quality Assurance… 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
- Arrowhead Pharmaceuticals (San Diego, CA)
- …and develop and execute regulatory plans. This position will report to the Director , Regulatory Affairs and collaborate with regulatory and other ... need. The Position This position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements… more
- Clinical Dynamix, Inc. (Florham Park, NJ)
- Job Description - AD/Dir Regulatory Affairs Reports To: SR Director - Regulatory Affairs . *Prepare and review various modules of ANDAs, and responses ... in a dynamic environment is required. *In-depth knowledge and experience of regulatory CMC documents review, and approval is required. *Provide regulatory … more
- Supernus Pharmaceuticals, Inc. (Rockville, MD)
- …Supernus products. Essential Duties & Responsibilities: Primarily responsible for Regulatory Affairs activities involving marketed products. Specifically, this ... and promotional materials for assigned products, submission of materials, and representing Regulatory Affairs on promotional review committee. Acts as primary… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research, and will support...reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Merck & Co. (Rahway, NJ)
- …the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Genmab (NJ)
- …various regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director , ... we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director ...Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development… more
