- 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 ... preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical… 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 ... RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of Regulatory … 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 ... CMC post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders to formulate regulatory strategies for… more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director , Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... is preferred and remote working possible **Location: Remote** **Reports To:** Executive Director , Global Regulatory Strategy, Dx/CDx and Medical Devices. All… 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 ... and registration strategies within the US and Canada. The Director will also provide line management, people development, and...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in ... candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations from various health authorities, as well… more
- BeOne Medicines (Emeryville, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics will be responsible ... of related experience working in data analytics in commercial, regulatory , market access or medical affairs function in a healthcare industry required- 4 or More… 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 ... Affairs strategic vision. This position will report directly to the Executive Director of Medical Affairs . Together with the Executive Director of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of Medical Affairs ... , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory ...and working toward building a quality mindset with Medical Affairs .Support the Sr. Director 's Medical Affairs… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The RoleGenmab is currently seeking a Director , HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an ... exciting, passionate, high profile, high impact Medical Affairs team, and work in a highly dynamic and...and work in a highly dynamic and collaborative setting.The Director , HEOL Team Lead is part of the US… more
- Coty (Morris Plains, NJ)
- …part of the global ingredient policy development and defense. This position reports to the Director , NA Regulatory Affairs and R&D Material Management and is ... Senior Manager, US Regulatory Affairs and Ingredient Support **SENIOR MANAGER, US REGULATORY AFFAIRS AND INGREDIENT SUPPORT** **COTY is looking for smart… 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
- 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
- Insmed Incorporated (NJ)
- …Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial ... 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 Hypertension… more
- Tris Pharma (Monmouth Junction, NJ)
- …collaborate closely with clinical leaders, statisticians, bioanalytical teams, and regulatory affairs to inform key development decisions.Designs non-clinical ... success.We have an opening in our Monmouth Junction, NJ Facility for a Director , Clinical Pharmacology. The Director , Clinical Pharmacology is responsible for… more
- Insmed Incorporated (NJ)
- …Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial ... 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
- Merck & Co. (North Wales, PA)
- …experienced, motivated, and passionate commercial talent to serve as the Executive Director , US Commercial Leader, for our Ulcerative Colitis Indication within our ... Collaborate with key stakeholders across the enterprise, including Medical Affairs , Manufacturing, Global Marketing, Global digital data and analytics, PDT/Research… more
- Merck & Co. (Montgomery County, PA)
- …the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as we work together to change lives for the better. The Position The Director , Media Relations & Issues Management is accountable for establishing and leading Novo ... to dramatically influence stakeholder perceptions. Relationships Reports to the Senior Director , Media & Stakeholder Relations, and interacts with senior leaders… more
