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Represent Global Immunology through strong collaborations with project teams, project heads, and other colleagues in various intra and inter-departments (GAD, CMC, clinical, regulatory) to advance the viral respiratory vaccine candidates into clinical trials.
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Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicated.
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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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Support state level government affairs relations including staying up to date on current issues and trends, assistance in arranging meetings as appropriate and making connections on behalf of the bank.
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10+ years of relevant regulatory/industry experience in biotech or pharmaceuticals with at least 8 years as the global Regulatory Affairs lead representative on project development teams that have led to marketing authorization.
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The candidate will be responsible for leading the Regulatory Affairs function and will oversee and direct the strategic planning and execution of non-clinical, CMC, and clinical regulatory activities essential for initiating and conducting clinical trials and securing marketing authorization.
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Broad experience in US and Global Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways.
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You are excited about leading the development of innovative CMC regulatory strategies and the preparation and submission of high‐quality CMC sections of INDs and CTAs, in close collaboration with regulatory team members, our in‐house CMC and Quality teams, contract manufacturing organizations, external experts and global health authorities.
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The ideal candidate will have a strong background in handling regulatory and compliance matters before the Texas Public Utility Commission, state energy regulatory commissions, and entities such as the Electric Reliability Council of Texas (ERCOT) or other ISO/RTOs or organized power markets.
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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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Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
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You will report to our Head of Regulatory Affairs and work side by side with your research and development colleagues to develop and execute innovative regulatory strategies for our development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
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Provide Regulatory Operations leadership during the implementation process of Veeva PromoMats in preparation for eCTD submissions to OPDP. Bachelor’s degree and/or Master’s degree with a minimum of 10 years relevant experience in pharmaceutical/biotechnology Regulatory Operations and project management.
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Minimum of 10 years of experience in global regulatory affairs, with a focus on CMC, in the pharmaceutical or biotechnology industry. Maintain effective communication with internal and external stakeholders to ensure alignment and understanding of CMC regulatory strategies and requirements including change control.
$240,000 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Associate Director, Public Affairs will serve as a critical Policy & Advocacy team member with responsibility for relations and collaboration with City and State legislators and regulators who make legislative, regulatory policy, and public policy decisions.
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Title: regulatory affairs Company: Sanofi in Cambridge, MA
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