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This role functions in a matrix team environment, interacting with several key stakeholder groups including Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Medical Affairs, Research, and Legal.
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Summary, Focus and Purpose The Regional Medical Scientific Director (Medical Science Liaison) is a credentialed (i.e., PhD, PharmD, DNP, MD) Director Level Medical Affairs position and therapeutic and disease expert who engages in bidirectional exchange of scientific or medical information with Scientific Leaders (SLs.
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Partner collaboratively with the Regulatory Affairs, Computational Biology, and Quality Assurance Teams across the enterprise to ensure that all procedural and submission documentation meets audit, compliance, and accreditation standards.
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2-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on regulatory operations. As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization.
$81,000 - $99,122 a yearFull-timeRemoteExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Overview The (OEA) at Tufts University School of Medicine is primarily responsible for the medical school academic programs, curriculum design and delivery, system-wide evaluation, faculty development, interaction with the offices of Student Affairs, Registrar, and Professional Degree Programs, and promotion of academic excellence through grant participation for innovative programs.
Starting at $70,000 - $87,550Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Serve as legal reviewer on promotional and medical review teams and partner with Commercial, Medical Affairs, and Regulatory Affairs to help ensure compliance, consistency, and accuracy in connection with promotional, medical, and disease awareness materials, publications, scientific and medical meeting materials, training materials, and materials for advisory boards, speaker programs, patient programs and the like.
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QualificationsTo be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
$103,500 - $170,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Bachelor's Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field. The Associate Director, Regulatory CMC executes multi-product global regulatory CMC strategies for cell therapy combination investigational and marketed products.
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Leads and collaborates in the development of post-approval global CMC regulatory strategies for an approved cell and gene therapy product. The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product.
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As Regulatory Affairs Specialist / Lead , you will guide our clients (Biotechs/pharmaceutical companies) to have a chance of getting regulatory approval for their therapies. Due to this increase in work and our international expansion, we just have released new openings for Regulatory Affairs Specialist / Lead US based to join our current team of specialists.
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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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Reporting to the VP of Program Strategy & Management, this person will work collaboratively to manage and integrate diverse R&D activities including but not limited to, preclinical research, clinical development, CMC, regulatory affairs, new product planning, business development and finance.
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The Public Affairs intern will support the Senior Vice President of Public Affairs in Washington, DC. The Public Affairs team is made of the Federal Policy & Advocacy, State policy, Advocacy and Community Relations, and Communications.
InternExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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This position reports to the Executive Director of MSLs. The MSL will have contact with internal colleagues in compliance, regulatory, pharmacovigilance, marketing, sales, research and development, medical science, medical information, market access, training, strategy and portfolio management, and HOVA. This internal collaboration is considered a fundamental and essential part of the position.
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Maintain effective and appropriate communication among internal stakeholders (Medical Affairs colleagues, Medical Information and Commercial Operations) while maintaining full compliance with relevant company, industry, legal and regulatory requirements.
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regulatory affairs jobs Title: principal consultant in Waltham, MA
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