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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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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 Yesterday - UpvoteDownvoteShare Job
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
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Draft, review and negotiate agreements for the quality, regulatory and medical affairs departments, including but not limited to, quality agreements, clinical trial agreements, services agreements, material transfer agreements and research agreements.
$157,000 - $204,000 a yearFull-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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The newly established Immune Health Initiative is hiring a full-time Regulatory Affairs Specialist or Senior Regulatory Affairs Specialist to assist with departmental IRB maintenance and submissions and to perform routine internal study monitoring for all observational clinical research studies.
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In coordination with the commercial strategy team, serving as day-to-day lead and strategic legal business partner to the commercial, medical and regulatory affairs teams, as well as patient advocacy/support teams, in connection with the Companys efforts to commercialize products.
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Having a broad outreach across wider organization, e.g., commercial, regulatory, med affairs. Leading cross-functional programs (e.g., across commercial, regulatory, med affairs) for legal.
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Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops on-going professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas.
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Communicate frequently with other Respiratory Sales Specialists across the country and cross-functional counterparts such as Marketing, Sales Ops, Market Access, Field Reimbursement, Training, and Medical Affairs to create alignment of business plan, focus on strategic drivers, and sharing best practices.
$140,000 - $170,000 a yearExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The Regulatory Law Unit's Airport Division is seeking a licensed Pennsylvania Attorney to fill an Assistant City Solicitor or Deputy City Solicitor position. The attorney will work on a wide range of transactional and compliance matters handled by the Airports Division, including negotiating and drafting of contracts and advising the airport staff on legal and regulatory matters, as necessary, for the City to operate and develop its two airports.
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Provide cross-functional strategic input to Pricing & Contract Strategy, Finance, Trade, Government Affairs, Policy, Cross-Brand, External Medical Relations, HEOR, Patient Assistance Programs, Field Sales, and the Global Market Access/Value group.
Full-timeRemoteExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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The mission of the Transcatheter Heart Valve (THV) Medical Affairs organization is to foster internal and external collaborations to generate and disseminate evidence-based best clinical practices to help save patients’ lives and advance quality of care.
$138,000 - $196,000 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Our department offers a wide range of programs, including a NASPAaccredited Master of Public Administration, an accelerated BA/MPA, an Executive MPA, an MS/PhD in Public Affairs, and a BA in Urban Studies and Community Development.
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The Senior Staff Attorney – Regulatory reviews and prepares litigation materials and various other documents, and advises, and represents the company in a variety of legal matters which may include but not be limited to regulatory, litigation, collections, bankruptcy, labor, municipal, energy, ethics and other areas requiring legal counseling and/or assistance.
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1 or More Years' experience including medical & scientific affairs, clinical practice, research, academic or US managed markets preferred. 5 or More Years' experience including medical & scientific affairs, clinical practice, research, academic or US managed markets preferred.
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regulatory affairs jobs Title: sr regulatory affairs associate in Philadelphia, PA
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