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Associate Director, Regulatory Affairs - CMC. The Associate Director of regulatory Affairs will be responsible for the development and execution of the Regulatory strategy for assigned programs in alignment with the corporate goals.
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The department of Financial Affairs at Boston University values intellectual, cultural, and social diversity among its staff and students. The IT Audit Associate is a key member of the Internal Audit and Advisory Services (IA&AS) team at Boston University.
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Proclinical is seeking a Director, Regulatory Affairs for a mid-sized oncology focused biotechnology company with their site in Massachusetts. Report to our Head of Regulatory Affairs and work side by side with your R&D colleagues to develop and execute innovative regulatory strategies for their 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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Minimum of 6 years of regulatory affairs experience in the biopharmaceutical industry, with a focus on rare diseases and orphan drug development. Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
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The Public Affairs intern will support the Senior Vice President of Public Affairs in Washington, DC. The Public Affairs team is made of the Federal Policy & Advocacy, State policy, Advocacy and Community Relations, and Communications.
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Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update to the teams on follow-up actions, information request, risk assessment and mitigation in support of clinical trial application and marketing application.
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Proven strong Medical Affairs skills (study design, management and conduct of studies, study evaluation, medical writing skills, expert panel conduct, symposium and workshop management, KOL management.
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Oversees corporate initiatives and works with local and federal government affairs to coordinate community affairs activities. Coordinate with Regional Government Affairs team on community investment programs.
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Awareness and continued pursuit of knowledge regarding global regulatory affairs trends and policies. Are you interested in a highly visible, global role that allows you to lead a team of regulatory experts while being part of the CMC regulatory leadership team to contribute to the advancement of a robust and innovative product pipeline.
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The Director of Regulatory Affairs reports to the Executive Director, Regulatory Affairs and will be responsible for developing and delivering global regulatory strategies for product development and approval in alignment with the corporate strategy for Stoke’s portfolio.
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Global Public Affairs (GPA) is a critical pillar of Global Corporate Affairs (GCA) with responsibility for engaging global policy stakeholders to advance patient-centered policy solutions to accelerate global, equitable access to Takeda’s innovative life-transforming medicines and vaccines.
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Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department.
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The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi's diversified portfolio in order to meet corporate and business objectives.
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This person will oversee the organization including development of strategies and supporting tactical execution for a wide array of sub-functions (Strategy and Operations, Field Medical Affairs, Medical Communications, Evidence Generation and HEOR, Patient Advocacy), interacting with senior leadership, and taking a “hands-on” approach in a lean organization.
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Reporting to the Senior Associate Dean for Academic Affairs and Student Services, the Academic Affairs and Student Services Coordinator will work in close collaboration and partnership with all Degree Programs team members and affiliated offices to support students and ensure successful planning, implementation, and continuous improvement.
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Title: affairs Company: Turnstone Biologics in Waltham, MA
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