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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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Reporting to the SR Director, Drug Product as part the CMC Technical Operations team the Principal Scientist, Drug Product, will provide strategic and technical leadership within the CMC Technical Operations to support the development and optimization of Akebia's clinical and commercial programs.
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Work in close collaboration with the Project and CMC teams and related functions, including discovery, non-clinical development, process development, analytical development, Quality and Regulatory teams.
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Departments include senior management, regulatory, QA, CMC, program management, finance, business development, medical affairs, clinical development and medical writing.) Experience in and understanding of end-to-end management of clinical trial conduct, the pharmaceutical industry, clinical drug development, clinical trials operations and regulatory components is essential.
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Strong knowledge of life science Clinical & CMC processes, including Regulatory Submissions (eCTD), Clinical Site Startup & Data Management. The leader in this role will be expected to cultivate and maintain strong relationships with technology and consulting vendors in the development systems business areas (Clinical, Regulatory, Biostatistics, Quality & CMC), ensuring that the organization is at the forefront of regulatory, clinical, and quality system advancements.
ExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products.
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Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. + Excellent communication skills and ability to provide concise summary to cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile.
$182,988 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
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Hands-on knowledge of cGMP and CMC regulatory requirements for cell or gene therapy manufacturing. Partnering with departmental leaders in CMC, Clinical Development, and Regulatory departments.
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Works in close collaboration with the Project Management and CMC teams and related functions, including discovery, non-clinical development, formulation development, analytical development, Quality Assurance and CMC Regulatory affairs.
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Experience authoring technical documents (process development, tech transfer, batch records, IND supporting documents) and supporting drafting of CMC sections of regulatory submissions (IND, IMPD, BLA.
$163,000 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Author and review drug substance CMC Module 3 sections including regulatory investigational (IND/CTA), registrational (NDA/MAA), and post approval submissions. Additional responsibilities include process optimization, preparing and reviewing regulatory filings, life cycle management, capacity planning to support development and commercial requirements and collaboration with peer CMC team members from IST’s internal and global partners.
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Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate.
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The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.
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Experience in providing regulatory CMC strategy for submission of clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for small molecule development compounds, including chemical drug, peptide and oligonucleotide.
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regulatory cmc jobs in Newton Lower Falls, MA
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