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A scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD.
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Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Provide CMC regulatory review for clinical protocols and investigator brochures, etc.
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The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.
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Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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Collaborate with cross-functional departments (including Research, Pharmacology, DMPK, Translational Medicine & Clinical Pharmacology, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance) to implement discovery & development of toxicology strategies to enable the progression of optimized drug candidates and ensure that toxicological considerations are integrated into all stages of product development.
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Build, maintain and advance partnerships with key stakeholders across Regulatory Affairs, Clinical Development, PDM, CMC Regulatory, Quality Assurance, Commercial functions, Information Technology and Development Systems to advance near-term regulatory priorities and long-term innovation efforts with broader enterprise level objectives.
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We are looking for an experienced Regulatory Affairs & Quality Assurance Lead to oversee our Mark I whole-body scanner regulatory submission and maintain market authorisation for our Gemini digital twin platform for compliance and commercial viability.
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Reporting to the Vice President, CMC Regulatory, CARGO is seeking an Associate Director, CMC Regulatory to help progress development of our cell-based gene therapy portfolio. The Associate Director will work closely with colleagues in Clinical Regulatory, Quality, Technical Operations, and Translational Medicine both as a leader and as an individual contributor for the development of effective product development strategies.
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10+ years of experience working directly in regulatory CMC or in a relevant technical development discipline, such as process development, analytical development, or quality assurance, including at least 6 years' experience directly in CMC regulatory.
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The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
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As SIRUM's first Legislative Affairs Director, you'll lead SIRUM's policy efforts across the country and be an integral part of shaping new drug donation policies nationwide. You have 3-5+ years of experience in legislative affairs, government affairs, and/or public policy (prior experience in healthcare or pharmaceutical policy strongly preferred.
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The ideal candidate must have experience in securities enforcement, white-collar defense, regulatory investigations, and compliance matters. Handle securities enforcement matters, white-collar defense, regulatory investigations, and compliance issues.
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Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections Partner with cross functional members across Gilead Pharmaceutical Development & Manufacturing (PDM), including Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC, Finance and Technical Development to ensure successful commercialization of the late-stage portfolio, as well as on time delivery of clinical and commercial product.
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Partners with all functional areas (translational research, CMC, regulatory affairs, clinical development, clinical operations, and pharmacovigilance) to build and maintain integrated project timelines, track progress, resolve conflicts, and communicate current project status.
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The candidate will work closely with Regulatory Affairs, Regulatory CMC, Quality, Global Patient Safety, Program Strategy Teams (PSTs), Development Teams, Clinical, and global affiliates.
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regulatory affairs jobs Title: sr director Company: Abbott Laboratories in Redwood City, CA
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