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Director, CMC Regulatory Affairs. 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.
$100 - $113 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
$80,059.2 - $106,059.2 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In collaboration with the Executive Director, Research Integrity and Compliance, leads external agency inspections and audits; provides support for audits and inspections to investigators, administrative teams and regulatory committees (i.e.
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Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity. The Associate Principal Scientist is responsible for developing and implementing Regulatory Chemistry, Manufacturing and Controls (CMC) strategies for assigned small molecule products in accordance with global regulations and guidance's, and Company procedures.
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We are looking for a Director of Regulatory Reporting, a leadership position within the team that is responsible for ensuring the overall integrity of trade and position reporting submitted to the regulators for the Fidelity Broker-Dealers, National Financial and Fidelity Brokerage Services, as well as for correspondent client broker-dealer firms.
$85,000 - $144,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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They will coordinate with other TA functions including Medical Directors, Alignment Director, Program Development Director and the Medical Liaison field team both within TA and across other TAs. This position will also coordinate with key functions across CMR (eg NACO), Public and Government Affairs and commercial.
$250,000 - $280,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Director, State Affairs influences public and government policy at all state government levels. Represent Humana at regional and national legislative, regulatory and other intergovernmental organizations in coordination with State Affairs policy team.
$185,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
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This position will work cross-functionally with the compliance, legal, corporate communications, investor relations, finance, operations, and marketing departments to understand the company’s global public and regulatory affairs goals.
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Job Summary The Associate Director, Global Regulatory Affairs Labeling, will be responsible for regulatory support in the area of product labeling. This position reports to the Director, Global Regulatory Affairs Labeling and will be responsible for creating, updating, and maintaining labeling documents throughout the product lifecycle, with primary focus on Company Core Data Sheets and regional/local labels for products marketed globally.
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Counsel and advise the BU in areas of product safety (including TSCA, FIFRA, FDA, OSHA Hazard Communication, Hazardous Materials Transportation), product regulatory affairs, product stewardship, and product risk management as such areas may impact the research, development, manufacture, marketing, sale, handling, transportation and advertising of the BU(s) products.
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Trinity Health Oakland Hospital, located in Pontiac, Michigan, has an excellent full-time employment opportunity for a Board-Certified Physician to serve as Medical Director of Quality, Safety, and Medical Affairs.
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Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders. You’ve acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K’s, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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Advisory support and coverage for Regulatory Relations, Regulatory Affairs, Risk Management (1 st and 2 nd Line), Regulatory Strategy, and other cross functional groups related to prudential regulatory matters.
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Reporting to: Vice President & Group Production Director. At least 7 years in business affairs administration. Overseeing Music licensing processes, ensuring appropriate rights and clearances.
$120,000 - $145,000 a yearFull-timeExpandApply NowActive JobUpdated Today
Title: director regulatory affairs Company: Unum Therapeutics
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