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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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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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Work closely with Global Patient Safety and Risk Management (GPSRM), Clinical Research, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs to inform clinical development and real-world outcomes and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies, EMR/claims data, and RWE. The Senior Director, Epidemiology reports directly to the Senior Vice President, Data Science, Statistics, and Epidemiology.
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine’s/Vertex network of external CMOs/contract labs to support company’s clinical programs.
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We're currently seeking a strong Regulatory Affairs Specialist, (RAS) who will work to ensure that company products and processes comply with all applicable regulations and standards. Bachelor’s or equivalent in Regulatory Affairs or related Science, along with 5+ years' experience in a related industry.
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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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Author clinical study protocol sections related to bioassays, reports and the bioassays sections of IND, IMPD, BLA/MAA, and other regulatory documents. · Partner with Clinical Science and Regulatory Science teams to provide subject matter expertise for diagnostic (and where applicable CDx development) for relevant asset(s.
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Reporting directly to the Head of Translational Medicine, this individual will oversee the design of translational/biomarker strategies and collaborate closely with cross-functional teams, including Research, Clinical Development, and Regulatory Affairs, as well as external CROs to ensure their seamless implementation into our clinical trials.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Join Takeda as a Senior Director, GRA - CMC Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives.
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The Communications Director shall coordinate with senior staff at MassDEP including the Chief of Staff, Deputy Commissioners, Government Affairs, and General Counsel, to plan and direct the Agency’s press strategy, including responding to media inquiries, sending press releases, coordinating social media, and managing press events.
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The Director of Student Affairs reports to the Associate Dean of Student Services and collaborates extensively with each of the programs and their different modalities as well as a multitude of university partners.
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Additional certifications in FDA law or regulatory affairs preferred. Proven track record of providing legal counsel on FDA regulatory matters. Conduct legal research and analysis on emerging FDA regulatory issues.
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Provide research and analysis on new projects and assignments related to Academic Affairs programs, including fiscal planning as necessary in support of Board of Trustees, Chancellor, Provost and Dean/Director level program reviews, UMass President’s Office, collective bargaining efforts and others as needed.
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Works collaboratively with the Graduate Medical Education (GME) Office and Compliance as necessary to ensure the appropriate fiduciary and regulatory responsibility of education and training programs.
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regulatory affairs jobs Title: director clinical assoc in Woburn, MA
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