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Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package ( briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions ( with FDA CDRH, EU notified bodies.
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Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems. Expertise in Veeva Vault or similar clinical trial management systems (CTMS), electronic trial master file (eTMF), or regulatory document management systems.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Collaborate externally with Drug Safety vendors and business partners on case management issues, processes, and timelines to meet global regulatory requirements for adverse event reporting and data exchange obligations.
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The Scientific Editor's responsibilities will be:Collaborate with scientists on nonclinical regulatory documents such as Investigator Brochures, Nonclinical Study Reports, Annual Reports, CTAs, INDs, and NDAs. Assume lead scientific writing responsibility on projects, utilizing regulatory and publication documentation expertise.
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Knowledge of regulatory requirements and standards for Biologics and Pharmaceutical manufacturing will be required. Compliantly and reliably transfer operations and procedures that will meet or exceed compliance and regulatory expectations in audits.
$200,000 a yearFull-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Global health regulatory agency knowledge and experience across GxP life cycle in Cell & Gene therapy and/or Biologics. The role will be responsible for supporting the development of the cell therapy quality strategy to meet business, regulatory, and operational requirements.
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BSI Consulting Services is a trusted and agenda-shaping partner providing ‘best practice’ technical, regulatory, and business expertise and intelligence for our clients’ most critical EHS, Supply Chain, and Digital risks and opportunities to achieve greater resilience, impact, and future-readiness.
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Compliance and Regulatory Oversight: In collaboration with organizational risk management and compliance leadership, ensures compliance with all federal, state, and local regulations governing FQHC operations, including HRSA, DPH, CMS, HIPAA, and NCQA PCMH requirements and standards.
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Reporting to the VP of Program Strategy & Management, this person will work collaboratively to manage and integrate diverse R&D activities including but not limited to, preclinical research, clinical development, CMC, regulatory affairs, new product planning, business development and finance.
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Providing guidance on FDA approval pathways and regulatory issues under relevant legislation. With a team of senior business lawyers with substantial in-house and general counsel experience, Outside GC provides private and public companies and non-profit organizations with outstanding corporate and IP legal services as needed at a fraction of the cost of either hiring a full-time general counsel or relying exclusively on law firm counsel.
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In-depth knowledge of global CMC regulatory requirements and guidelines (FDA, EMA, ICH, etc. Train and mentor staff on CMC regulatory requirements and best practices. Qualifications: BS or BA in scientific discipline Advanced degree (Ph. D., MS, or equivalent) in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field preferred 8-10 years of experience in regulatory CMC within the biopharmaceutical industry Proven track record of successful regulatory CMC submissions and product approvals.
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External Affairs consists of Communications, Government and Regulatory Affairs, Labor and Workforce Planning, and Community Engagement teams. Senior Regulatory Affairs Manager. Minimum of five years of public policy and regulatory or legislative experience.
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Is accountable for oversight of timely preparation and quality of Preclinical DMPK sections of regulatory documents (IND, NDA, briefing books, Investigator Brochures, etc.) May be a point of contact for government regulatory agencies for their function.
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Strong knowledge of and/or experience with government programs regulatory, operational, financial, and clinical requirements for the delivery of health insurance and managed care products and services, including Medicare, Medicaid, MMP, LTSS, SNP, Duals, CHIP, and behavioral health, as well as the associated and relevant federal, state, and local regulatory entities.
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regulatory job Title: principal consultant Company: Parexel in Somerville, MA
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