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In-depth knowledge of CMC regulatory requirements for Advanced Therapy Medicinal Products and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products.
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May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director.
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With general guidance from the Senior Director, Regulatory Affairs and Corporate Stewardship, the Regulatory Affairs Manager will lead the Association’s policy agenda and coordinate regulatory and legislative priorities in the areas of infrastructure and environment, health & safety (EHS.
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The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new/modified product, regulatory operation and processes, post-market surveillance.
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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred) Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) A solid understanding and experience in drug development including early and late development is highly preferred.
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We’re a leader in staffing Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, HEOR, Market Access, and Sales & Marketing roles. Medical Science Liaison, Hematology/Oncology (Northern CA) TMAC (TMAC Direct) - San Francisco, CA, United States Tagged: MSL, Medical Affairs, Medical Science Liaison, Oncology, Hematology , Field Medical , Pharmaceutical, TMAC Direct Hire Hematology/Oncology MSL Expansion – Top BioPharma CompanyTMAC’s direct-hire service, formerly known as TMAC Direct, is an executive search firm and Pharma’s Complete Recruiting Resource.
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It can be valuable for candidates involved in the development and submission of IVD products to regulatory agencies like the FDA.Regulatory Affairs Certification (RAC): A certification in regulatory affairs, such as the RAC from the Regulatory Affairs Professionals Society (RAPS), can be beneficial for candidates involved in FDA IVD application processes.
$118,000 - $147,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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We are looking for an experienced Regulatory Affairs & Quality Assurance Lead to oversee our Mark I whole-body scanner regulatory submission and maintain market authorisation for our Gemini digital twin platform for compliance and commercial viability.
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A thorough understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology, as well as the emerging paradigm for cell & gene therapy. Precigen is advancing an exciting pipeline of novel cell and gene therapy products and to further our efforts we are seeking an Executive Director, Medical Affairs who will be instrumental in creating and building the global medical affairs function at Precigen for our first commercial launch.
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Business group: Intel’s Legal, Trade, and Government Affairs (LTG) group offers unique opportunities to work in a variety of areas, including counsel to Intel businesses; technology and intellectual property licensing; patent prosecution; trademarks and brands; litigation, mergers, acquisitions and investing; public policy, legislative and regulatory lobbying; global trade, export, import, and customs; and corporate compliance.
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POSITION OVERVIEW: The Regulatory Affairs, Accreditation & Safety Specialist (RASS) provides regulatory and safety expertise as related to Joint Commission, CMS, Oregon Health Authority, Pharmacy Board, OSHA, and other regulatory agencies.
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The Director, Transmission Policy Advocacy be based out of Invenergy’s Washington, D.C. office and report to the SVP, Transmission Public Affairs while collaborating closely with Invenergy’s federal affairs, regulatory, permitting, and transmission business functions.
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Reporting directly to Executive Director, Regulatory CMC. Your expertise will play a pivotal and visible role in advancing CMC. Directs and coordinate regulatory activities of external consultants in consultation with Global Executive Director or designee.
$197,000 - $232,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The successful candidate will work collaboratively with the dynamic Federal Legislative Affairs team, as well as regulatory and business teams, to develop policy positions, formulate lobbying strategies, and coordinate Hill outreach to drive desired outcomes on critical issues.
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Hold a degree in Political Science, Public Administration, International Affairs, Government Relations, Economics, Law, or similar; Schneider Electric has an opportunity for a Manager, Regulatory Government Relations in Washington, DC.
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regulatory affairs jobs Title: account executive
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