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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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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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Reports to: Executive Vice President and Managing Director, Chief Counsel, Head of Global Regulatory Affairs. Position Title: Counsel/Senior Counsel, Regulatory Affairs (position title and compensation is commensurate with experience.
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Advanced life science degree or certification in Regulatory Affairs Sciences preferred. Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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The Senior Grassroots Manager reports directly to the Vice President of Regulatory, Labor and State Affairs but collaborates closely with all members of ABC’s Government Affairs team.
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Quality and Regulatory Affairs Specialist. The Quality and Regulatory Specialist facilitates and participates in the implementation of the multidisciplinary hospital and system wide Clinical Quality and Patient Safety Performance Improvement Program.
$87,692 - $131,538 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Assist the Regulatory Affairs Specialist in preparing, submitting, and processing approvals from the IRB and other Penn review entities for new research studies as well as for continuing reviews, modifications, reportable events, and study closures throughout the life of a study.
$43,919 - $52,661 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
$143,300 - $286,700 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred) Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA) A broad knowledge of development and life-cycle management is preferred.
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HJF is seeking a Regulatory Affairs Specialist to assist in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA.
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We invested in new offices, sector teams and practice groups including higher education; foundations; investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and creative services.
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Work with internal leaders and their teams such as Market Access, Policy Legal, HEOR, Regulatory Affairs, Finance, and Medical Affairs to identify and assess public polices and proposals that would impact AbbVie and lead the development of government affairs strategies to mitigate or improve government proposals.
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This position is based in our Princeton, NJ office with onsite presence 60% of the time and reports to the Head of Regulatory Affairs. As a key member of the Regulatory Affairs leadership team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company.
$206,250 - $343,750Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
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regulatory affairs jobs Company: Medical Solutions in IN, Pennsylvania
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