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The Regulatory Affairs Senior Specialist I, NPD is responsible for evaluating and ensuring labeling accuracy for Cepheid’s in vitro diagnostic products. Senior Regulatory Affairs Specialist I.
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We are seeking a seasoned, technically proficient Regulatory Affairs Director, CMC. This individual is someone who can thrive in a fast-paced, innovative environment to help develop and drive the success of regulatory affairs.
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The Senior Director, Regulatory Affairs CMC will be responsible for planning and executing the CMC regulatory strategies for Celldex’s therapeutic development programs. Industry experience of 10 years, of which at least 8 years spent in regulatory affairs with CMC responsibilities.
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10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs and small molecules.
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As time allows, the Manager for Regulatory and Legislative Affairs will also assist in representing the Trust's interests at the Maine Legislature and other policy and regulatory forums.
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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
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Join Arkema in Wauwatosa, USA, as a Product Stewardship and Regulatory Affairs Specialist. If you are a driven individual with an interest in regulatory affairs and product stewardship, apply now.
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Track animal care and sustainability developments in legislative/regulatory affairs across species (cage-free, animal medication/housing, etc.) Work alongside Coca-Cola corporate teams to identify issues, legislative, regulatory, and lobbying opportunities.
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The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.
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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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Work closely with Global Patient Safety and Risk Management (GPSRM), Clinical Research, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs to inform clinical development and real-world outcomes and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies, EMR/claims data, and RWE. The Senior Director, Epidemiology reports directly to the Senior Vice President, Data Science, Statistics, and Epidemiology.
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In conjunction with the AVP, Medical Affairs NA - Biologics and Market Access, will be the responsible member of the Sun Pharma medical department in regulatory interactions, ISS and expert advisory board meetings, external professional societies, seminars, and conventions.
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Experience: Eight (8) years of professional experience developing and/or implementing policy, advocacy, government affairs or regulatory affairs; including, three (3) years of supervisory experience.
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Guides, directs and evaluates (1) Associate General Counsel, (3) Lease Administration Department (1) Senior Paralegals and, (2) Scientific & Regulatory Affairs Department. Provide guidance to Scientific and Regulatory Affairs on regulatory issues related to both product and procedures, including label safety, use of third party literature, and training documentation.
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We invested in new offices, sector teams and practice groups including higher education; foundations; 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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regulatory affairs jobs Title: director clinical Company: Novartis Farmacutica in Troy, New York
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