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Expert knowledge in cloud architecture, DevSecOps, vulnerability management, and familiarity with regulatory frameworks such as SOC, ISO, and FedRAMP. - Develop, implement, and maintain compliance and regulatory guidance and security and privacy self-assessments for cloud and traditional data center environments.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department.
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Experience in bioanalytical assay development and qualification based on regulatory guidelines. AIRNA is seeking a highly motivated Research Associate/Senior Research Associate to join our Preclinical Development team in Cambridge, MA and assist in executing activities associated with AIRNAs drug development programs advancing novel therapeutics to the clinic.
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The successful applicant will operate at an extremely fast pace, working with other global project team members including physicians, regulatory leaders, CMC representatives, discovery scientists, and assay development experts.
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The Associate Director of Regulatory Operations is responsible for the assembly, publishing, and submission of regulatory filings to global Health Authorities (HA) in an efficient and timely manner.
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Oversee the preparation of numerous reports to internal departments and external regulatory agencies, specifically Board of Directors, HMDA, CRA, HUD, FDIC, Investors and Bank Commission, to ensure accuracy, integrity and timeliness of reports.
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Participates in regulatory inspections and company audits including FDA/MHRA/EMA PV inspections; assists with prepares responses to audit findings that concern the DSPV department. Reporting to the Associate Director, Drug Safety and Pharmacovigilance Compliance and Operations, you will play a pivotal role in drug safety activities, supporting records management and compliance across the clinical development and marketing programs.
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Group representation on cross functional teams which may include members of QC, Upstream/Downstream Process Development, Manufacturing, QA, and Regulatory. You will author reports and SOPs, along with contributions to our Regulatory Submissions.
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Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions. We are seeking a motivated Scientist/Sr. Scientist to join our Analytical Research and Development team and perform method development and qualification for lot release and characterization of cell and gene therapy products and critical materials.
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Specific domain knowledge of biotech lab processes, biological systems, and regulatory standards. FL97 is seeking a dedicated and skilled (Sr.) Automation Engineer to join our team. Flagship has created over 100 groundbreaking companies since 2000, including Moderna (NASDAQ: MRNA), Generate Biomedicines, Tessera Therapeutics, Indigo Ag, Inari Agriculture, and Sana Biotechnology.
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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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Assist in the preparation of CMC regulatory submissions, including providing data summaries and trend analysis. Additional responsibilities will include preparation and review of analytical CMC documentation, contribution to authoring and review of analytical sections of regulatory submissions.
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Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization.
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Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, clinical and immunogenicity assay development.
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regulatory job Title: sr regulatory affairs associate in Lexington, MA
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