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Interface with and drive collaboration between the various functional teams: Platform Discovery, Medicinal Chemistry, CMC, Disease Biology/Pharmacology, DMPK/ Preclinical Drug Safety, Regulatory & Medical Affairs and Clinical and with the Leadership Team on program-related matters.
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This position will report to the Senior Vice President, General Counsel Commercial and and will require you to work in a matrix setting in a fast paced, rapidly growing organization, partnering effectively with various stakeholders, including with colleagues in across the Commercial Legal team as well as Medical Affairs, Commercial, Regulatory, Ethics & Compliance, Privacy and other expertise areas at Alnylam.
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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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The Regulatory Affairs Specialist (RAS) positions are critical to successfully achieving ongoing clinical research expansion and regulatory compliance at DFCI.The selected candidate may only work remotely within the New England states (ME, VT, NH, MA, CT, RI.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
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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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Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs and Clinical Operations.
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The Director will chair the respective neurology TA Global Publications Team as well as engage with cross-functional partners including but not limited to research, clinical development, marketing, market access, medical affairs, regulatory affairs and biostats.
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Bachelor's degree required with 8 or more years work experience in government, government relations, or regulatory affairs, preferably in a state or municipal government setting. The Senior Manager for Intergovernmental Policy and Regulatory Affairs for Harvard Public Affairs and Communications (HPAC) manages relevant University interactions with state and local agencies and regulatory bodies to coordinate and advance the University's priorities.
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Significant in-house experience advising on data privacy, data protection and the legal and regulatory aspects of product development in the technology space (experience at a consumer-facing, Internet company preferred.
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Minimum 6-8 years of experience in the pharmaceutical/biotechnology/life science industry, including at least 4 years of regulatory affairs CMC experience, including direct experience in developing and executing global regulatory strategy.
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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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Work collaboratively with other Medical Directors, and colleagues in Biostatistics, Medical Writing, Drug Safety, Clinical Operations, Translational Medicine, and Regulatory Affairs. Collaborate with Regulatory Affairs to align studies with local, national and international health authority requirements.
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Minimum 15 years of relevant biopharmaceutical industry experience, with at least 10 years' experience in Regulatory Affairs and deep experience in oncology; precision medicine given preference.
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regulatory affairs jobs in Newton, MA
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