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The Senior Manager/Associate Director, Regulatory Operations will report to VP, Regulatory Affairs and Quality. We are expanding our Regulatory Affairs team to include a Regulatory Operations function that will support development and commercialization activities of our therapeutic candidates.
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We are currently seeking a Regulatory Affairs Associate Director to join our growing regulatory team. Associate Director - 5 – 7 years of experience in Regulatory Affairs (strong preference for experience in oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Partnering with team members and other functional areas including Regulatory Affairs, Clinical Pharmacology, Clinical Development, Quality Assurance, Legal, Data Management and Biostatistics to perform study related activities.
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You’ll be engaged in projects dealing with International tax, mergers and acquisitions, state and local tax accounting, regulatory processes, tax reporting and strategy. Real Estate: Advise clients on their federal, local and overseas tax affairs, while acting as a strategic consultant related to: deals and transactions (including mergers, acquisitions and investments, conversions, reorganizations, dispositions, joint ventures, fund formation and structuring, etc.
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Experience working cross functionally with greater CMC/Technical Operations team, Quality Assurance and Regulatory Affairs. Contribute drug product expertise in support of global CMC regulatory strategy.
$194,000 - $237,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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The Sr. SMA/SMA will also work cross-functionally with other groups such as Clinical Development, CMC/Supply Chain, Regulatory Affairs and Project Management. Knowledge of FDA regulatory requirements and ICH/GCP guidelines.
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Lead late-stage drug product development activities including scale-up, design of experiments (DOEs), risk assessments, and development of the integrated control strategy in partnership with other CMC functional areas, Quality, Regulatory Affairs, and Manufacturing.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Director - 7-10 years of experience in Regulatory Affairs plus 3-5 years proven experience in a leadership role with strong management skills. In this role you would be the Global Regulatory Lead where you will develop and implement global regulatory strategies to support the development of multiple oncology early development assets, contributing to the advancement of leading edge cancer research in a nimble, biotech like environment within a large, well established pharmaceutical company.
Full-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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We are seeking a highly motivated Regulatory Affairs and Quality Assurance (RA/ QA) experienced professional to join DermBiont. Knowledge of GLP and GCP, Pharmacovigilance (PV), ICH, FDA requirements and guidelines for small molecules, including drafting, interpreting, and implementing quality assurance policies and procedures for regulatory documents, as well as establishing document management activities.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Proven experience in the generation of relevant regulatory sections of IND filings. We are seeking an experienced and highly motivated small molecule formulation scientist with a proven record of sustained laboratory achievement and innovation to join our growing Department of Pharmaceutical Sciences (PharmSci/CMC) at ORIC Pharmaceuticals.
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Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Associate Vice-President/Vice-President in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.
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Collaborate closely with cross-functional teams, including clinical development/operations, regulatory affairs, clinical supply management, data management, and medical affairs, to drive quality improvements across all clinical trial processes.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Our lawyers and legislative advisors serve domestic and international clients in all areas of corporate and business law, complex litigation, intellectual property, regulatory matters, and government affairs.
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The AD CSM establishes and maintains effective communication and collaboration with functional area peers including Drug Safety, Quality Assurance and Regulatory Affairs, as well as thought leaders in order to meet program objectives and support achievement of goals.
$139,500 - $189,500 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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They are looking for a Regulatory Affairs contractor for 10 hrs a week, who will be responsible for aiding and working in a fast pace accelerated environment. B.S/M.S in biochemistry, molecular biology, or related discipline with 2-3 years of Industry experience.
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regulatory affairs associate jobs in San Francisco, CA
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