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Stays up to date and compliant with the regulatory landscape related to drug safety and data analyses. Minimum of - years of experience in data analysis, statistical modeling, and data visualization, preferably within the biopharma or healthcare industry.
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Position Summary:The Zoetis Global Medical Affairs team is recruiting a board-certified veterinary dermatologist to provide best in-class veterinary medical leadership for the Zoetis dermatology portfolio.
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Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs, etc.
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The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Senior Director, Global Regulatory Affairs Strategy. Work closely with regulatory CMC lead and overall development team to insure overall regulatory strategy and regulatory CMC strategy are aligned.
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This remote contract position will lead regulatory operations activities and manage US and global submissions for the Regulatory CMC group. Sr. Manager, Regulatory Operations Management- Contract - New Jersey.
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Partnership across Medical Affairs, RW V&E, JRD, Brand Marketing, Regulatory Affairs, Global Medical Affairs, New Business Development, J&J Corporate Communications, and J&J Legal, field based Medical Affairs personnel.
$59.13 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ideally 1 year in regulatory affairs or 2-3 years in a complementary functional area (eg, clinical research) Additional responsibilities, in conjunction with regional and/or global regulatory leads, include: o IND, BLA, and NDA maintenance submissions o Safety and Annual report submissions (regulatory components) o Coordinating and driving rapid response team meetings to ensure quality and timely responses to health authority queries.
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Strong collaboration with internal and external business partners including regulatory, brand marketing, Real World Value & Evidence (RW V&E), Janssen Research & Development (JRD), Global Medical Affairs, epidemiology, clinical investigators, advocacy organizations, and key external experts.
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Partnership across Medical Affairs, RW V&E, JRD, Brand Marketing, Regulatory Affairs, Global Medical Affairs, New Business Development, Pharmaceutical Corporate Communications, and Pharmaceutical Legal, field based Medical Affairs personnel.
$59 an hourExpandUpdated 7 days ago - UpvoteDownvoteShare Job
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Partnership across Medical Affairs, RW V&E, Brand Marketing, Regulatory Affairs, Global Medical Affairs, New Business Development, Corporate Communications, and Legal, field-based Medical Affairs personnel.
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A demonstrated track record of successful business experience in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs, Regulatory Affairs, Sales, Marketing, Legal, etc.
$195,500 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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One (1) year of experience in conducting legal research, analyzing and evaluating legal documents, rules, regulations, and/or legislation, or the review and analysis of regulatory matters in a government agency; or one (1) year of experience as an attorney.
$111,000.8 a yearFull-timeExpandUpdated 15 days ago - UpvoteDownvoteShare Job
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Strong knowledge of International Safety Protocol (ISP) and Global Food Safety Initiative (GFSI), Standards and Regulatory Requirements of FDA FSMA, HACCP Programs. Lead the sites in all Food Safety, Quality, and Regulatory related activities for animal feed, water conditioning and industrial grade products, when applicable at location.
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Strong knowledge of regulatory and commercial compliance issues relating to conducting research and disseminating of scientific information is required. Job Description: Health Economics & Outcomes Research (HEOR) Consultant, will be responsible for all statistical aspects of research conducted by the HEOR function, such as statistical input into study design, the analysis and reporting plan, and the analysis and interpretation of results.
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Leveraging key contact relationships with federal, state, community and local officials to successfully manage and advance political and regulatory strategies in concert with the company's Rates, Governmental/Regulatory Affairs and Economic Development groups.
ExpandApply NowActive JobUpdated 12 days ago
Title: regulatory affairs Company: Sanofi in Trenton, NJ
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