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Lead cross-functional teams (e.g. pharmacovigilance, biostatistics, clinical operations, and regulatory affairs). Provide medical leadership for internal and CRO cross-functional teams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
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Senior Director, Global Regulatory Affairs Development Pipeline, Cell Therapy. Define and oversee oversight plans for vendors active in regulatory affairs on behalf of BioNTech.
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We've placed hundreds of professionals including executives, managers, veterinarians, sales reps, and more in areas including professional services, research and development, pharmacovigilance, regulatory affairs, marketing, sales, etc.
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Interacts extensively with regional and corporate departments to provide medical/drug safety strategic input to clinical research (scientific and operational), regulatory affairs, and global quality/manufacturing.
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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.
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Manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. Defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global Company locations or contract manufacturing organizations (CMOs), or alliance partners.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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You will work across divisions including stakeholders across Global Marketing, Commercial Leadership, Research & Development, Medical & Scientific Affairs, Operations, Quality Assurance & Regulatory Affairs and Finance.
$118,000 - $236,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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The successful candidates will have 5+ years of accounting experience working in the captive management industry to manage the financial and regulatory affairs of a portfolio of captive insurance companies.
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PhD in biomedical sciences or related fields, with a degree or certification in regulatory disciplines or Regulatory Affairs Certification (RAC) as a plus. Expertise in regulatory submission structure and content, including IND, CTA, MAA, NDA, BLA, and extensive knowledge of regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA, and other international regulatory agencies.
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This position reports to the Senior Director, Rates and Regulatory Strategy and is responsible all regulatory affairs and rates for Liberty’s gas and water utilities in New York. The Director will lead a team of regulatory professionals and be responsible for effective engagement with state regulators and key stakeholders to advance Liberty's interests and initiatives, the preparation of rate cases and compliance filings, and development of regulatory strategy.
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This position reports to the VP, Global Regulatory Affairs. Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Cross-Functional Collaboration: Work collaboratively across departments to integrate brand strategy, fostering partnerships with Sales, Medical Affairs, Market Access, Regulatory, and Legal teams to achieve aligned objectives.
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Regulatory Affairs Specialist IV. Minimum of 8 years experience in Regulatory Affairs, or equivalent combination of education and experience relating to IVD/Medical Devices/Biologics.
$107,200 - $147,400 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Work closely with Commercial, Medical Affairs, Regulatory Affairs and Pharmacovigilance in development of clinical plans that meet both regulatory and commercial needs. Interface and maintain strong relationships with KOLs in the relevant therapeutic areas and regulatory bodies to ensure optimal development of the portfolio.
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Lead and mentor a team of regulatory affairs professionals, fostering their growth and development. cresilon.com The Director of Regulatory Affairs (RA) is a functional leader of Cresilon.
$160,000 - $220,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago
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