- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... registration and life cycle support and the leadership of regulatory strategy for projects that are currently US...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Insmed Incorporated (San Diego, CA)
- …for each other, 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 ... communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from...and experience in the development and execution of Global regulatory strategyIn-depth knowledge and direct application of US… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for reviewing the ... person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer...CMC post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... development, regulatory , and registration strategies within the US and Canada. The Director will also...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- Insmed Incorporated (NJ)
- …values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive ... certification as a Great Place to Work® in the US , and a place on The Sunday Times Best...Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve… more
- Merck & Co. (North Wales, PA)
- …responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution. ... Mergers and Acquisitions (M&A), Negotiation, Out Licensing, People Leadership, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Regulatory Affairs … more
- BeOne Medicines (Emeryville, CA)
- …affairs , legal, healthcare compliance and other business functions primarily in the United States with some activities globally to ensure compliance with ... or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline + and 5 years… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Medical Director , Medical Affairs - Dermatology role will be responsible for supporting the ... person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer...vision. This position will report directly to the Executive Director of Medical Affairs . Together with the… more
- Coty (Morris Plains, NJ)
- Senior Manager, US Regulatory Affairs and...policy development and defense. This position reports to the Director , NA Regulatory Affairs and ... Ingredient Support **SENIOR MANAGER, US REGULATORY AFFAIRS AND INGREDIENT SUPPORT** **COTY is looking for smart leaders who are fast and passionate!** **We… more
- Genmab (NJ)
- …dynamic and collaborative setting.The Director , HEOL Team Lead is part of the US Field Medical Affairs leadership team responsible for the execution of the ... Medical Affairs strategy in support of the US business objectives. The Director , HEOL Team...knowledge and adherence to corporate complianceCurrent working knowledge of US -specific legal, regulatory , and compliance regulations and… more
- Merck & Co. (Upper Gwynedd, PA)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… more
- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... medicine.Summary, Focus and Purpose:The Cardiovascular and Respiratory Clinical Research Director -has primary responsibility for planning and directing clinical research… more
- Eisai, Inc (Ann Arbor, MI)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... profile, we want to hear from you. The Associate Director / Director , MSLs is responsible for the leadership,...in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe 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.Under the guidance of...development of American Managed Care Pharmacy (AMCP) dossiers for US payers and Global Value Dossiers for use by… more
- Insmed Incorporated (NJ)
- …cross-functional partners, including ex- US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial ... of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for...Affairs , and Commercial Effectiveness to ensure alignment of US HCP activities with field execution.Partner with Agency of… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …strategy.Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs , Clinical, and Program Management.Maintain up-to-date ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… more
- Insmed Incorporated (NJ)
- …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 ... Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial… more
- Eisai, Inc (Nutley, NJ)
- …that drives optimal access and utilization of Eisai marketed products in the United States .Provide input to the health economics and outcomes research ... your profile, we want to hear from you. The Director , US HEOR and RWE (field) is...the employment eligibility of all new hires in the United States . Please click on the following… more
- Merck & Co. (North Wales, PA)
- …role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the ... of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams,… more
