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May be a team leader and contributes to the leadership of RCMC.You will be responsible for:Lead the development and implementation of global CMC regulatory strategy supporting CGT products.
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Regulatory expertise in project leadership, preferably negotiation with and conduct of meetings with the FDA and successful preparation and submission of IND/CTA/MAA/NDA/BLA with explicit CMC focus for biologics and/or small molecule modalities.
$167,000 - $241,925 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
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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.
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QUALIFICATIONSA 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. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
$295,290 - $382,140ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Hands-on knowledge and experience and track record of success in CMC Regulatory requirements Cell & Gene Therapy, and Biologics (FDA, EMA, ICH, etc. This role will partner with the Biopharmaceutical Sciences CGT team on a variety of strategic, operational, and organizational matters across three pillars: CMC Project Leadership, Project Management and leadership team (LT) operations.
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The Oncology CMC cell therapy group sits within the Cell Therapy Technical Operations (CTTO) group in the Oncology Research and Development department and operates cross-functionally and globally to develop innovative cell therapies.
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Experience placing Regulatory Affairs professionals in CMC, Ad Promo, Labeling, Regulatory Strategy, etc. Recruiting Practice Director, Regulatory Affairs (Pharma) Cultivating long-term partnerships with key stakeholders in Regulatory Affairs.
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The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriad’s gene therapy product development, registration, and post-approval strategies.
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Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
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Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities.
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Possess deep understanding of the external global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization applications.
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The Associate Principal Scientist is responsible fordeveloping andimplementing Regulatory CMC strategies forassignedsmall molecule products in accordance with global regulations andguidance's, andCompany procedures.
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The Associate Director, Clinical Pharmacology, will be responsible and accountable to lead and execute clinical pharmacology strategies and activities for assigned programs and studies from early through late-stage clinical development and approval, including post marketing activities, and collaborate cross-functional stakeholders including research, DMPK, translational medicine, clinical development, clinical operation, biometrics, regulatory, CMC, and project management.
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