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Proclinical Staffing is seeking an Associate Director of Regulatory Affairs to join a top medical program. Associate Director of Regulatory Affairs - Permanent - Onsite.
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The Associate Director of Regulatory Operations is responsible for the assembly, publishing, QC, submission, and archiving of regulatory filings to global Health Authorities (HA) in an efficient and timely manner.
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Effectively collaborate to ensure alignment and success with cross-functional partners including Market Research, Analytics, Corporate Affairs, Patient Services, Medical Affairs, Regulatory, Legal, Compliance, Market Access, etc.
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About the Position Reporting to the Associate Director, Medical and Regulatory Writing, the Senior Manager, Regulatory Technical Writer will be a key member of the Clinical Development organization and interface with cell therapy clinical, nonclinical, and manufacturing research personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators.
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Reporting to the Associate Director of Regulatory Affairs, the Veeva Quality Assurance Lead will serve as a lead for the Veeva Quality Assurance Specialists in day to day operations, will review, itemize and migrate all regulatory documentation from the current document management system to the SiteVault platform.
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Takeda Development Center Americas, Inc. is seeking an Associate Director, Global Regulatory Affairs Strategy - Oncology in Cambridge, MA with the following requirements: Master's degree in Biotechnology, Biochemistry, Business, Science, or related field, or foreign academic equivalent, plus 4 years of related experience OR Bachelor's degree in Biotechnology, Biochemistry, Business, Science, or related field, or foreign academic equivalent, plus 6 years of related experience.
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Our attorneys and governmental affairs professionals work on a multi-disciplinary basis in regulatory counseling, litigation, transactional, and government relations matters on a broad array of issues.
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As an Associate Director, Field Medical Affairs, you will play a pivotal role as a field-based, medical science liaison with Ophthalmology expertise. Sustains expertise in product/ molecule data, disease state management, emerging therapies, and the competitive landscapeResponds to customer inquiries with integrity, compliance, and adherence to legal, regulatory, and Regeneron guidelines, policies & procedures, to support the accurate use of products and servicesSupports clinical research activities through phases 1-4, focusing on identification of pre-clinical, clinical and post-marketing study investigators/ specialists and sites.
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The successful candidate will support the firm's full-service government law and policy practice, which includes a broad range of litigation, counseling, regulatory, and transactional work. Candidates should have 1-5 years of experience handling complex legal matters, ideally with political savvy - this can include work in government or on campaigns before or since law school.
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Communicate effectively and collaborate cross-functionally with colleagues in research, development (e.g. PK/PD, biostatistics, non-clinical & clinical operations) and regulatory affairs to support drug discovery and development programs.
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A bit about us:Our client, an award winning advertising agency, is looking to an a Freelance Associate Director, Regulatory! Benefits OfferedRemoteJob DetailsJob Details:We are looking for a dynamic and driven Contract Freelance Associate Director, Regulatory to join our fast-paced Marketing team.
$40 an hourExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identify issues; offers creative solutions and strategies, including risk mitigation strategies.
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Effectively collaborate with internal partners, including the network team, compliance, litigation, privacy, state regulatory affairs, government affairs, procurement, SIU and other business units and Cigna Affiliates to provide interpretative and practical advice on a variety of legal and business decisions.
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You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling requirements are met for assigned products.
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Build the Regulatory Operations infrastructure and oversee development of standard operating procedures, training materials, and job aids with respect to Regulatory Affairs and Operations.
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regulatory affairs associate jobs in Philadelphia, PA
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