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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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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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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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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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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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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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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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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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Resolve complex, escalated compliance issues within Quality Assurance and Preclinical/Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data management and Pharmacovigilance.
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Key ResponsibilitiesStrategy and Execution:Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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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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Act as the primary legal subject matter expert, reference and point-of-contact for the Technical Operations functions at Sana, including Manufacturing, Quality, Process Development, Supply Chain & CMC Portfolio, External Manufacturing, External Supply & Procurement, CMC Regulatory Affairs, Analytical Development & Operations and other Technical Operations teams.
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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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Researches energy policy and evaluates business impacts to ensure the company remains competitive under evolving federal and state regulatory environments. Experience with regulatory agencies including FERC and PUCs in AZ, CO, TX, NM. Criteria/Conditions: Position requires travel up to 25% of the time.
$118,000 - $165,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago
regulatory affairs jobs Title: assistant Company: Enlivant
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