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The Sr. Regulatory Specialist, LATAM will prepare and submit regulatory compliance documents with regulatory authorities, and advise on regulatory affairs that stem from the U.S. Company's activities in the Latin American (LATAM) region.
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I-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Quality Assurance and Bioinformatics. Lead Mechanical Engineer / LME. Lead Mechanical Engineer opportunity to work for a top 10 premier CDMO. This position is working on a well funded site that will be growing over the next 3 years.
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We invested in new offices, sector teams and practice groups including higher education; foundations and nonprofits; investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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Collaborate with cross-functional teams, including research, clinical development, biostatistics, and regulatory affairs, to define biomarker strategies and integrate companion diagnostics into clinical trial protocols.
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The Senior Grassroots Manager reports directly to the Vice President of Regulatory, Labor and State Affairs but collaborates closely with all members of ABC’s Government Affairs team.
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Minimum 2+ years of experience working in Regulatory Affairs, Product Development, Medical Affairs, or related role within the dietary supplements or food industries. The US Regulatory Affairs Sr. Associate – Wellness is responsible for end-to-end regulatory activities for the Wellness portfolio, which is comprised of primarily dietary supplements.
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Partners with Sr. Privacy Counsel, Cyber Security, IT, Regulatory Affairs and Enterprise Risk Management to help manage privacy risk exposure. Partners with Sr. Privacy Counsel, Cyber Security, IT, Regulatory Affairs and Enterprise Risk Management to help manage privacy risk exposure.
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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The Director will work closely and collaboratively with the broader policy advocacy team and Government Affairs functions, and across Gilead departments with shared external relationships-including Public Affairs, Medical Affairs, and Commercial.
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As a Director, Regulatory Affairs, Vaccines you will e nsure the development and execution of the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP.
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As the focus of this internship, we would like to study the potential for how generative AI can be used in the drug development lifecycle to accelerate the approach to areas such as regulatory filings, generation of real world evidence, clinical trial documentation and audits.
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This role is part of a global cross-functional team and interacts with Global Clinical Development, Clinical Management, Regulatory Affairs, Biostatistics, Global Medical Affairs, Commercial, Market Access, Government Affairs, and other colleagues to stay abreast of clinical development program needs for value differentiation in alignment with the target product profile across the product lifecycle.
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Fifteen (15) years of experience in Regulatory Affairs and Quality experience in the biotechnology, medical devices, or pharmaceutical industry with increasing responsibility (including interfacing with FDA and other regulatory agencies in development and commercialization of new medical technologies.
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regulatory affairs jobs Title: director Company: Govhr Usa
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