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The Analyst III – Policy & Regulatory Operations is responsible for Local, State, Federal, contractual and accreditation requirements interpretation, gap analysis, project scope development and initiation, resource planning, risk identification and mitigation, and project implementation, as well as timely comprehensive development, review and maintenance of internal and Provider policies, and other regulatory documents.
$80,059.2 - $106,059.2 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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As the newest Regulatory Affairs Manager, you will be responsible for registering current and newly acquired crop protection products in the U. As a Regulatory Affairs Manager, you will interact with internal and external customers, including state/provincial and federal regulatory authorities, in support of Nova Source products.
$7,500 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Provide legal advice and support for our U.S. businesses and Environmental, Health, & Safety team covering a broad range of environmental, safety, and regulatory issues. 5 to 15 years practicing law with experience in environmental or regulatory work (5 years of law firm/private practice experience preferred.
$190,000 - $240,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Alexion, AstraZeneca Rare Disease is seeking a highly motivated co-op with educational experience in Regulatory Affairs. This co-op student will be a member of and support regulatory subteam activities and work on a variety of projects across Regulatory Affairs (RA) including Development Strategy, Established Products, Labeling, Operations, CMC, Advertising & Promotion, and Clinical Trial Excellence.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Effectively represent the Global Regulatory Affairs (GRA) function in senior-level interactions at internal governance technical review committees, key global health authority meetings, and external partners.
$165,200 - $236,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice. We are looking for someone who already has an interest and established foundation in regulatory affairs and human subjects research, and/or specialized knowledge of working with cellular therapies.
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Engages with cross-functional team members in Clinical Affairs, Operations Center of Excellence, Professional Affairs, Health Economics and Market Access, R&D, Regulatory, and Medical Safety and Infection Prevention & Control to review clinical evidence and to evaluate a product’s risk-benefit calculus.
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
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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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Engage regularly with colleagues within Corporate Communications (Social Media & Corporate Brand Storytelling); across External Affairs (Patient Engagement & Advocacy and Government Affairs); and cross-functionally in Employee Communications, Market Access, Medical Affairs, HEOR, Legal, Regulatory and Investor Relations to understand each functions objectives and drive an aligned approach to product communications and stakeholder message harmonization.
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Supports the Director, Regulatory Law, Government Affairs and Trade Compliance in managing risk within the defined scope of responsibility. Reports to: Director, Regulatory Law, Government Affairs and Trade Compliance.
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Familiarity with other HSE aspects (i.e., occupational safety, plant/process safety, distribution safety, product safety/regulatory affairs, management systems, crisis and incident management) of benefit.
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Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas. Board Certified in therapeutic area and US fellowship training, or MD with 2-4 years’ experience in within the pharmaceutical industry including 2 years in-house Medical Affairs role, or PhD or PharmD with 5 years’ experience within the pharmaceutical industry, including experience in the therapeutic area and 3 years in an in-house Medical Affairs role; MD preferred.
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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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regulatory affairs jobs Title: regulatory affairs project manager Company: Meet
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