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Dragonfly Therapeutics is seeking a Head of Regulatory Affairs, title commensurate with experience, and reporting directly to the COO, to lead our Regulatory Affairs organization.
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Reporting to the Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs – CMC will be responsible for leading, developing, and executing CMC regulatory strategies on programs ranging from early to late-stage development, including preparation and filing of IND and NDA/MAA submission.
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Reporting to the Senior/Executive Director or Vice President of Regulatory Affairs, the Director of Regulatory Affairs – CMC and Compliance will be responsible preparing CMC regulatory strategies that enable first pass approvals.
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Acumen Pharmaceuticals is seeking a Director, CMC Regulatory, reporting to the Vice President, Regulatory Affairs, to lead the development, implementation, and execution of CMC regulatory strategy, including global submission strategy for investigational applications, clinical trial support, compliance, marketing application strategy, and CMC change management, ensuring compliance with global regulations (e.g., FDA, EMA, MHRA, HC, PMDA, CFDA, ANVISA.
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HJF is seeking a Regulatory Affairs Specialist to assist in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA.
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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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Associate Director, CMC Regulatory Affairs. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Interface effectively with all other BMS internal stakeholders: Global Medical Affairs functions and other departments, including Commercial, Clinical Research and Development, Regulatory Affairs, Managed Care, Pharmacovigilance, Market Access, Statistics, Translational Research/Development, Project Leadership, etc.
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Role: Regulatory Affairs Specialist. Prepare reports responding to inquiries from ERCOT, other RTO/ISOs, and regulatory or government agencies. Follow developments before Public Utility Commission of Texas (PUCT), Texas legislative proceedings, and other regulatory or government agencies that affect gas and power marketing and trading activities and report on such developments to relevant groups within the company.
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The Regulatory Affairs Specialist will provide regulatory support for the Catalent Cell and Gene Therapy sites. This position will evaluate facility change controls for compliance with applicable change control guidance and will maintain site master files and Type V DMFs. In addition, the Regulatory Affairs Specialist will provide audit support and assist in preparing for group meetings and communications as appropriate.
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The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.
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As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
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Job Title: Regulatory Affairs Manager (Retail Energy + Wholesale Market in OH, IL, PA, MI) At least 7-10 years of prior working experience in regulatory affairs, policy advocacy, governmental licensing and permit processes in a retail and wholesale energy business setting.
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Partner with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review and track regulatory documents. Understand the impact of DMPK/BA and interdependencies with other functional teams within the enterprise including Pharmacology, Toxicology, Clinical and Regulatory disciplines.
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The Senior Manager, 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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regulatory affairs jobs Title: regulatory affairs assistant Company: Jobget
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