- Nura Bio (South San Francisco, CA)
- …conferring neuroprotection, across diseases of the central, peripheral, and ocular nervous system. The VP/ Head of Regulatory Affairs will be a key member of ... alignment with regulatory requirements. *Mentor and develop the regulatory affairs team, fostering a culture of continuous learning and professional growth.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across functions.Provide leadership and guidance on assigned programs, collaborating closely with the Head of Development and Medical Affairs QA to implement the ... in quality and compliance.Evaluate risks impacting GxP compliance within Medical Affairs , driving ongoing improvements to meet regulatory requirements and… more
- Insmed Incorporated (NJ)
- …Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial ... 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
- 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 ... **General Description:** This role is the head of Promotional Regulatory , and provides...affairs , and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development,… more
- Insmed Incorporated (NJ)
- …Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial ... 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 suppurativa)… more
- CSL Behring (King Of Prussia, PA)
- The Head of Global Regulatory Affairs - Advertising and Promotion is responsible for leading and overseeing the regulatory strategy and compliance of ... MD, JD, or equivalent) preferred; Bachelor's degree required. -12+ years of Regulatory Affairs experience, with at least 8+ years specifically in advertising and… more
- Sanofi (Cambridge, MA)
- Global Project Head -AATD* SAR447537 Development The Global Project Head (GPH) is delegated various responsibilities by the Senior GPH and/orTherapeutic Area ... Head to provide leadership, supervision, and coordination within the...GPH will be delegated such responsibilities as interaction with regulatory /health authorities (HA), approval of documents and product label,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, marketing, medical affairs , market access and policy/advocacy (MAPA), regulatory affairs , and other relevant NNI departments to ensure alignment ... to drive market share and revenue growth. Partner with legal, regulatory , and medical affairs for timely review and approval of promotional materials Market… more
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... the investigations are conducted and written in compliance with all cGMP regulatory as well as facility requirements. This individual will be responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to ... processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …background. **Job Description** We are seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function ... **Skills & attributes:** + Understanding of North American pre-and post-marketing regulatory requirements for medical Affairs and Medical Information activities.… more
- Sanofi (Morristown, NJ)
- …matrix management with internal and external stakeholders: US and Global Medical Affairs , NA Corporate Integrity Agreement Monitors, Legal, Regulatory , Finance, ... Medical Program Lead (MPL) will, in collaboration with the relevant Medical Head , lead the strategic direction and operational execution of the medical brand… more
- HP Inc. (Washington, DC)
- …with all related stakeholders both internally and externally. The position reports to the Head of the Americas - Government Affairs & Public Policy. **Essential ... **Federal Government Affairs Manager, HP Inc.** The Federal Government ...strategies for achieving growth goals and objectives. + **_Policy /Legislative/ Regulatory analysis_** - Stay abreast of current trends and… more
- Sanofi (Morristown, NJ)
- …one of the Global Business Units. This position reports directly to the SILC Head and plays a vital role in shaping Sanofi's future launch capabilities. We are ... core launch standards, ensuring tailored approaches based on product type, regulatory environment, and market access conditions. You will continuously refine and… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …through Internal Collaboration: Forge strong collaborations with clinical development, medical affairs , and regulatory teams to ensure seamless integration of ... **Vice President, Head of Global Market Access** **Job summary** Sun...Pharmaceuticals is looking for a dynamic, experienced, and motivated Head of Global Market Access. As a leader in… more
- ITG Brands (Greensboro, NC)
- …responses, including strategy, redactions, and risk mitigation. Partner with Quality and Regulatory Affairs teams to support consumer complaint intake, quality ... Regultaory team. This senior-level role will report to the Head of Regulatory Law and focus on... environments and support business objectives. Collaborate cross-functionally with Regulatory Science and Affairs , Corporate Legislative … more
- CSL Behring (King Of Prussia, PA)
- …is onsite three days a week. You will report to the Executive Director Head Regulatory . **Position Description** **Summary** **-** ** Regulatory leaders who ... outcomes.** **-** **Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus...lead product health authority interaction with support GRL or Regulatory TA Head .** **-** **Partner with GRAST… more
- CSL Behring (Waltham, MA)
- …is onsite three days a week. You will report to the Executive Director Head Regulatory . **Position Description** **Summary** - Regulatory leaders who support ... (PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA… more
- CSL Behring (King Of Prussia, PA)
- …of 6 years of experience in the life sciences industry, with exposure to regulatory affairs or a related function. -Strong analytical, data interpretation, and ... three days a week. You will report to the Head of Global Regulatory Science and Policy....FDA). - **Cross-functional Collaboration** Liaise with GRAS, clinical, medical affairs , and quality assurance teams to ensure alignment on… more
- CSL Behring (King Of Prussia, PA)
- …**Qualifications & Experience Requirements** Bachelor's degree required. -8+ years of Regulatory Affairs experience, with at least 6+ years specifically ... onsite three days a week. You will report to the Executive Director, Head , Global Labeling & Labeling Data Strategy. The Director, Global Advertising and Promotion… more
