- 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 ... (fast track, RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP 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 ... lentiviral, gene editing, cell-based therapeutics), a strong understanding of regulatory requirements, and the ability to work cross-functionally in a fast-paced… more
- CSL Behring (King Of Prussia, PA)
- **The Opportunity** As the Senior Director , Medical Affairs , you will lead the development and execution of Medical Affairs strategies and tactics to support ... leaders in relevant fields + Review and approve medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs , and Commercial +… 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 ... therapies that make a meaningful difference worldwide. Could you be our next Director , Global Advertising and Promotion? The job is in our King of Prussia,… more
- CSL Behring (King Of Prussia, PA)
- …data collection and submit all reports needed for compliance. 4. Work with Senior Director , Policy Advocacy & Government Affairs , & Legal to interpret and ... of biotech/pharmaceutical experience. **Experience** + Strong knowledge of the regulatory requirements for MDRP, Medicare/IRA, Veteran's Healthcare Act, and other… more
- CSL Behring (Waltham, MA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... days a week. You will report to the Executive Director Head Regulatory . **Position Description** **Summary** -...one key region (EU, US, Japan) -Experience working in Regulatory Affairs with agency interaction responsibility with… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Role Overview** The Sr. Director , Clinical Development is an experienced clinical trialist who will be responsible ... into clinical development programs both externally and internally (eg, Medical Affairs , Commercial, CROs, etc.). They will provide clinical / scientific support… more
- University of Colorado (Aurora, CO)
- **Program Director of Regulatory Affairs ** **Description** **University of Colorado Anschutz Medical Campus** **Department: Medicine - ClinImmune - The ... Center for Clinical Immunology** **Job Title: Program Director of Regulatory Affairs ** **Position...Affairs with oversight of the ClinImmune Cell and Gene Therapy, Histocompatibility, Stem Cell Laboratories and Cord Blood… more
- Sumitomo Pharma (Lincoln, NE)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and...is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will… more
- Sumitomo Pharma (Boise, ID)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the US,...of the Global Regulatory Affairs (GRA) team based in the US. He/she will… more
- Fujifilm (College Station, TX)
- …more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers **Job Description** **Reports to** Director , Regulatory Affairs **Work Location** ... **Position Overview** The Regulatory Affairs Specialist II is responsible...From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Partner across Kite Medical Affairs , Clinical Development, Translational Medicine, Regulatory Affairs , and Product Teams to build integrated cross-functional ... Kite and help create more tomorrows. **Job Description** The US Medical Senior Director , MA Evidence Generation at Kite Pharma, a Gilead Company, will provide… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …mindset and is recognized as a trusted partner and subject matter expert in regulatory affairs . Your expertise spans global regulatory filing strategies, WHO ... Senior Program Officer, you will report to the Deputy Director of Regulatory Strategy and Product Support....other foundation operational resources. + Experience in health product regulatory affairs , from research and clinical development… more
- Lilly (Boston, MA)
- …being accountable for submissions, and taking part in meetings. + Represent the regulatory affairs team on cross-functional project teams and provide guidance to ... is headquartered in Boston, Massachusetts. **The Position** The purpose of the Associate Director , Regulatory Strategy role is to support the development and… more
- Orchard Therapeutics (Boston, MA)
- …or PhD in a scientific discipline preferred. . At least 15 years experience in Regulatory Affairs in the Biotech environment, spanning US regulatory science ... Location: Boston, MA Main responsibilities The Executive Director (ED) Regulatory Science will actively...therapy highly desired; experience in the technical development of gene or cell-based therapies and associated regulatory … more
- Gilead Sciences, Inc. (Oceanside, CA)
- …and complex supply chains. + Certification in auditing (eg, ASQ, IRCA) or regulatory affairs . + Familiarity with digital audit tools and data analytics ... providing mentorship, performance evaluations, and long-term career development. The Director ensures compliance with global regulatory requirements, marketing… more
- Sumitomo Pharma (Olympia, WA)
- …addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of ... seeking a strategic, collaborative, and execution-focused leader to join us as ** Director , Strategic Planning & Effectiveness - Oncology Portfolio** . This role is… more
- Astellas Pharma (Northbrook, IL)
- …is strategically communicated to internal stakeholders and external audiences. The Director will work closely with Research and Development leaders, leveraging ... strategies are seamlessly integrated within the broader pipeline strategy. The Director will oversee early-phase publication planning, working closely with Subject… more
- Fujifilm (College Station, TX)
- …Collaboration** : Work closely with the Quality Assurance, Manufacturing, and Regulatory Affairs teams to support product development and ensure ... **Position Overview** As the Associate Director of Microbiology, you will play a pivotal...a contamination-free environment, support our product pipeline, and ensure regulatory compliance. **Company Overview** The work we do at… more
- CSL Behring (King Of Prussia, PA)
- …to ensure platform performance and compliance. Bachelor's or Master's in Life Sciences, Regulatory Affairs , Health Informatics, or related field. 10+ years of ... the strategic execution and governance of pharmacovigilance (PV) and regulatory platforms to ensure operational efficiency, compliance, and scalability. Drives… more
