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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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All who are selected to participate in CFRs Blavatnik Internship Program and Robina Franklin Williams Internship Program receive training in the field of foreign policy and international affairs as well as skills training in writing, research, program planning and much more.
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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
$295,290 - $382,140ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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The Public Affairs Specialist – Content Creator internship offers an invaluable opportunity to contribute to community outreach and media relations efforts, enhancing public understanding and engagement with land management and conservation practices.
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The Army public affairs specialist participates in and assists with the supervision and administration of Army public affairs programs primarily through news releases, newspaper articles, Web-based material and photographs for use in military and civilian news media.
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Director, CMC Regulatory Affairs – Biologics. Head of CMC Regulatory Affairs – Small Molecules. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
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Bluebird bio is seeking an accomplished and adaptable Director Medical Affairs to join the medical affairs team, focused on our gene therapy programs for Sickle Cell, Beta Thalassemia, and CALD. You will be joining a passionate and committed flock, flying closely with medical birds as well as the cross functional teams.
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10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs / small molecules.
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In addition, the person in this role will have the opportunity to support other legal teams in USG Legal Affairs through drafting, reviewing, negotiating, and interpreting writer/producer agreements, nonwriting executive producer agreements, director agreements, and other entertainment-related agreements.
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Regulatory Affairs, CMC, IND, IMPD/CTA, NDA, MAA, GMP. Director, Regulatory Affairs CMC. Lead the preparation and maintenance of the CMC / quality sections for regulatory submission, including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.
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KOSU seeks a multimedia journalist to work as an Indigenous Affairs Reporter. Indigenous Affairs Reporter. KOSU seeks a multimedia journalist to work as an Indigenous Affairs Reporter. Two years' experience as news producer, journalist, and/or announcer.
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Support other legal groups in the USG Legal Affairs team. Work with the Legal Affairs team and colleagues in the Law Department on major projects with long-term business implications. Must be authorized to practice law in the State of California (Must be either (1) a member in good standing of the State Bar of California; or (2) MIP registered in-house counsel in California.
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This individual will build strong cross-functional relationships with Gilead’s Value and Access, Medical Affairs, Regulatory, Legal, and Public Affairs teams. Partner as appropriate with US Federal Government Affairs to align Gilead’s outreach with key US Government Agencies, such as the State Department, the Department of Health and Human Services Office of Global Affairs, the US Department of Commerce, USTR and relevant departments to support regional objectives.
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The primary purpose of this position is to serve as a Public Affairs Specialist, to carry out a wide range of assignments that include media operations, community engagement, command/visual information, communication planning, contingency/crisis response, special event planning, environmental, security, policy review, and resource management in support of the mission.
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affairs job Title: regulatory affairs specialist Company: Jazz Pharma
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