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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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This includes providing solutions-oriented feedback and working collaboratively with other cross-functional team members, such as Medical Affairs, Marketing, Legal, and Regulatory. Support content development in Concept and/or Draft phases within the Medical Affairs and Commercial and teams, including MSL Training, MSL Content, Medical Directors, Scientific Communications, Medical Information, and Medical Training; including Medical Affairs project submission in Veeva Vault as needed.
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Collaborate with cross-functional teams, including analytical development, process development, quality assurance, and regulatory affairs, to ensure seamless project progression. Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
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Reporting directly to the Assistant Vice President of Student Affairs and Chief of Police, the Associate Director, Student Affairs Business Systems plays a critical role in managing nine enterprise applications and multiple non-enterprise systems.
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Liaise with the Government Affairs, Regulatory Affairs, Origination and Community Impact teams at Reactivate's JV parents Invenergy and Lafayette Square to coordinate efforts and leverage a broader understanding of market and community dynamics.
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This role works closely with key stakeholders including CMC, Supply Chain, Development, R&D, Clinical, Regulatory Affairs and Project Management to define the analytical capabilities required to effectively manage Dyne's complex clinical supply chain and support eventual launch and commercialization efforts.
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Work closely with individual clinical teams as well as functional area partners (e.g., Translational research, Precision Medicine and diagnostics, Regulatory Affairs, Market Access, Clinical Development) to identify and implement end-to-end Data Science solutions aimed at facilitating decision making.
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This position supports three teams within Berklee Academic Affairs—faculty development, graduate studies, and institutional research and assessment—and contributes directly to a broad range of institutional functions including graduate student success, accreditation processes, and faculty and chair professional development offerings.
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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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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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In this role, you will support and partner closely with the Company’s management team to support all functional groups, including research, development, manufacturing, alliance management, licensing and collaborations, intellectual property, regulatory affairs, human resources, finance, accounting, corporate governance, SEC filings and investor relations, business development and corporate development.
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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 16 days ago - UpvoteDownvoteShare Job
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As a Senior Regulatory Affairs Specialist at Verily, you will work closely with other Regulatory Affairs team members, experts from diverse fields (e.g., Biology, Chemistry, Physics, Electrical Engineering, Computer Science) to develop, manage and execute regulatory strategies to obtain market clearances for innovative products.
$166,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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As a Legal Counsel/Assistant General Counsel within the global Regulatory Law team, you will be the second U.S.-based lawyer with a Regulatory Law focus. Legal Counsel/Assistant General Counsel, Regulatory Law Location: Boston, MA, US.
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As a pivotal leader within the Division of Student Affairs, the Director of Residence Life reports to the Senior Associate Dean of Students and oversees a large and multifaceted residential program.
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regulatory affairs jobs Title: assistant Company: Citi in Boston, MA
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