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At minimum 10 years’ experience in the pharmaceutical industry in Biologics/Research & Development/Regulatory Affairs. Ensure strategic regional regulatory input which is in consideration of the commercial strategy and is provided into global regulatory teams and that the Regional Regulatory TA Team supports the Global Regulatory Affairs (GRA) vision of excellence, good scientific practice, integrity and compliance with regulatory standards.
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Apply locations Radnor, PA USMO Remote USCT Remote USOK Remote USMN Remote time type Full time posted on Posted Yesterday job requisition id R-154388 Avantor’s Legal Department is seeking a Senior Counsel, Litigation and Investigations (Commercial and Regulatory) to support client groups within Avantor’s enterprise, reporting to Vice President, Deputy General Counsel, Litigation.
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The Associate Principal Scientist is responsible fordeveloping andimplementing Regulatory CMC strategies forassignedsmall molecule products in accordance with global regulations andguidance's, andCompany procedures.
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O Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by the group.
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Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC) and team members to enhance these relationships.
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This role works closely with the Chemistry, Manufacturing and Controls (CMC), Regulatory Affairs, and Quality Assurance departments, as well as with cross-functional project teams. This role provides CMC Regulatory expertise and leadership for commercial and development projects.
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As a trusted leader, the Compliance Director, Regulatory Exam Response will provide direction to a dynamic team of compliance professionals focused on carrying forward the tone for regulator engagement and exam and inquiries response on behalf of Vanguard Marketing Corporation, an affiliated self-clearing broker dealer and distributor of Vanguard products.
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Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs. Ensure that regulatory strategies also consider non-regulatory market access issues (e.g., health technology assessments, payor demands.
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In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK up to VP level and representing GSK GRA in interactions with key regulatory agencies (EMA, CBER, PMDA etc.
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Senior Regulatory Specialist - 10 years experience - of CMC , regulatory strategy, project management , scientific advice. Responsibility to: Regulatory Manager/Team Leader Direct relationships: Head of Regulatory Associate Director Regulatory Senior Management team QPPV & QP (UK & EU) Other staff External development partners and clients External consultants and contractors Regulatory Authorities.
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This role requires an extensive knowledge of the roles and responsibilities of Regulatory Affairs spanning both clinical and commercial phases of drug development, and how Regulatory Affairs connects with other functional areas.
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Direct, train, motivate and manage product safety regulatory specialist who supports chemical regulator management (e.g., TSCA, global registrations,) programs 15% Excellent understanding of US laws and regulations pertaining to chemical regulatory management – particularly TSCA Canada DSL/NDSL, etc.
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The Lead Regulatory Affairs Specialist leads the preparation of document packages for regulatory submissions for new and sustaining enhanced technologies, software enabling and robotics systems within the Surgical Intelligence (SI) portfolio, to ensure compliance with local and regional registration requirements.
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Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements.
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Will lead a cross functional team that handles critical regulatory compliance programs throughout AmeriGas. The compliance responsibilities include Process Safety Management (PSM), Risk Management Program (RMP), Office of Pipeline Safety (OPS), and Department of Homeland Security (DHS) related activities.
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Title: regulatory Company: Coda Searchstaffing in King Of Prussia, PA
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