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Transamerica is organized by lines of business (Life Insurance, Annuities, Mutual Funds, Retirement Plans, and Employee Benefits), which are supported by Transamerica Corporate (Corporate Development; Finance; Internal Audit; Legislative, Regulatory & Policy; Office of the CEO; People and Places; Brand; Corporate Affairs; Risk; and Technology.
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The Sr. Director, Global Medical Affairs- Hemophilia is a critical member of the Medical Affairs and Patient Engagement leadership team and is responsible for defining the Global Medical Affairs vision, contributions to the integrated strategy (which also includes market access and marketing components) & tactics, and integrated evidence plan that support Spark’s late-stage product development and commercialization objectives through Roche.
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We are currently seeking a Regulatory Affairs Associate Director/Director to join our growing regulatory team. 5 – 7 (Director)/ 7 – 9 (Associate Director) years of experience in Regulatory Affairs (strong preference for experience in oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment.
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The NCI/NCTN Senior Regulatory Affairs Start-Up Specialist is expected to resolve, with minimal supervision, regulatory queries, and participate in the initiation of the new study, as well as, communicate transition of the new study to the applicable team Regulatory Affairs Specialist post-site initiation.
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Since being founded the team has seen phenomenal and sustained organic growth, working across Medical Affairs, Publications, Promotional, Commercial and Regulatory spaces for their roster of blue-chip pharmaceutical companies and biotech's.
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Must possess a thorough understanding of the FDA, OIG, HIPPA, PhRMA, GCP and other international regulatory/ethical guidelines relevant to the pharmaceutical industry & clinical trial conduct, and to ensure compliance with these external as well as internal Eisai guidelines and standard operating procedures.
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Collaborate with US Government Affairs team to identify and develop policy priorities related to commercial market access. Minimum of 10 years of experience in health policy, market access, and reimbursement, including comprehensive knowledge of commercial payment systems and the healthcare regulatory environment.
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Collaborate with cross-functional teams, including regulatory affairs, quality assurance, manufacturing, and marketing, to ensure successful product development and launch. In-depth understanding of regulatory requirements and processes for biologics development.
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This position requires an aplished candidate with strong academic credentials, political acumen, relationships with state Department of Insurance officials and state legislative officials and staff, as well as a developed technical background in regulatory and legislative matters for all lines of property and casualty insurance (P&C), including workers'pensation.
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They have immediate need for a well-qualified Director of Regulatory Affairs to support an R&D team charged with developing effective small molecule (drug)-imaging agents. Provide overall leadership of the regulatory function, interfacing with the Clinical, Quality Assurance and CMC teams.
$300,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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The Pharmaceutical Regulatory Affairs Senior Manager will use their experience and knowledge in pharmaceutical industry regulatory affairs to lead and manage complex projects for our clients in the pharmaceutical sector, and provide strategic advice, guidance, and solutions on regulatory matters.
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Accomplished public policy professional with at least 10 years' experience in international government affairs roles in governments, think tanks or business associations responsible for healthcare, commercial trade, regulatory, or intellectual property.
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Must understand regulatory affairs and their applications to Quality Control and Quality Assurance; understand the application of federal, local and institutional regulations as they apply to the conduct of human subjects research.
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Provide practical and timely legal guidance on issues related to clinical, biometric, medical affairs, patient advocacy, regulatory affairs, pharmacovigilance, program and asset management, commercial development, pricing & reimbursement, sales, marketing, market access, patient services, and government affairs.
$306,700 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Present relevant legislative and regulatory measures and Jefferson impact along with relevant Hospital Association summaries during regular Government Affairs team meetings and during standing meetings with Senior VP, Government/External Affairs and Jefferson Leadership team.
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regulatory affairs jobs in Philadelphia, PA
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