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Carry out advocacy strategies to influence policies that impact pediatric rare disease patients and Soleno in collaboration with government affairs consultants. Minimum of 5-7 years of experience in government affairs, lobbying, or a related role, with a strong understanding of the legislative and regulatory process.
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Job Description Sr Manager, Statistical Programming Key Skills:Successfully interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis.
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This role is expected to closely collaborate with multiple teams across Process Development, MSAT, Analytical Development, Regulatory Affairs, Quality and Manufacturing. The Sr. Engineer/Scientist in Process Development, CMC will focus on commercialization and post-commercial process optimization of allogeneic cell therapy manufacturing processes.
$150,000 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Work closely with the Head of Scientific Affairs & Strategic Partnerships and Scientific Affairs team to produce rapid, thoughtful responses to content-related requests from across Pfizer Oncology (CSO, Medical strategy, BoD, Investor Relations, colleagues, etc.
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8+ years relevant experience in quality control, quality assurance, and regulatory affairs at a Class I or Class II medical device manufacturer. We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.
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The Sr. Manager/Associate Director, Regulatory Affairs will be a strategic thinker responsible for overseeing (with support) the regulatory assessment and research on regulatory precedence to evaluate regulatory strategies for development programs focused on precision medicine.
$195,000 a yearFull-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Collaborate effectively with colleagues from various disciplines including Medicinal Chemistry, Pharmacology, and Regulatory Affairs to achieve project goals. Strong expertise in synthetic organic chemistry, including multi-step synthesis and reaction optimization.
$184,000 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Collaborates with Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations.
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Internal Collaborations – Manufacturing, Quality Control, Quality Operations, Process Development, Analytical Development, Supply Chain, Regulatory Affairs, Alliance Management, among others. Internal Collaborations – Manufacturing, Quality Control, Quality Operations, Process Development, Analytical Development, Supply Chain, Regulatory Affairs, Alliance Management, among others.
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The Sr. SMA/SMA will also work cross-functionally with other groups such as Clinical Development, CMC/Supply Chain, Regulatory Affairs and Project Management. The Sr. SMA/SMA will maintain oversight over CROs and key study CSPs to ensure quality conduct of trials and data collection and work closely with study sites/investigators.
$130,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, and Quality to ensure appropriate reporting of PV and drug safety information and support risk mitigation measures.
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Advise internal cross-functional team who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, & others such as Commercial. Global Regulatory Affairs Strategy roles (U.S. and Canada) can be based in either South San Francisco or North Chicago, IL.
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As we expand our portfolio and prepare for commercial entry to the oncology market in the US and EU, we have an exciting opportunity for a Sr Director, Regulatory Affairs - Advertising, Promotion, and Labeling to support the commercialization of our late-stage programs.
$296,500 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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5-10 years of experience in the pharmaceutical industry, including 3-5 years in Regulatory Affairs. Scientific Search has partnered with a commercial stage pharmaceutical company based out of the West Coast that is searching for a Sr. Manager – Associate Director of Regulatory Information Management.
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Demonstrated competency and experience supporting Regulatory, Medical, and Clinical Affairs teams to ensure compliance for our Life Science and MDx products and tools around human disease and genetics.
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affairs job Title: sr in San Mateo, CA
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