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The Senior Grants and Contracts Manager will support innovative research at the world's leading public health research institution, primarily in the Department of Global Health & Population.
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Reporting into the Senior Manager for Origination, the Senior Regulatory Affairs Specialist’s primary responsibilities are to support Repsol’s natural gas trading/origination teams through communication of regulatory changes affecting natural gas and electricity markets and the external advocacy for the protection and betterment of Repsol’s commercial interests.
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Minimum 5 years in Regulatory Affairs within any of the following industries: pet food, food, OTC drugs, medical devices or pharmaceuticals; Create and foster a climate of teamwork and effective working relationships both within Regulatory Affairs and with our internal business partners: Quality, Marketing, Legal, New Product Innovation, Science & Technology, Professional Veterinary Affairs, Supply Chain, and others to achieve the synergy needed to effectively work as a team and promote the business.
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Support Manager, Product Safety & Regulatory Affairs in efforts to effectively advocate the Company’s product safety and product stewardship positions with trade associations, government agencies and non-governmental organizations.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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The Senior Director, Regulatory Affairs CMC will be responsible for planning and executing the CMC regulatory strategies for Celldexs therapeutic development programs. Celldex Therapeutics Director/Senior Director, Regulatory Affairs CMC New Haven , Connecticut Apply Now.
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The Manager of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements.
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The successful candidate will work collaboratively with the dynamic Federal Legislative Affairs team, as well as regulatory and business teams, to develop policy positions, formulate lobbying strategies, and coordinate Hill outreach to drive desired outcomes on critical issues.
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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.
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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2) Business Relationship Management: • Foster close relationships with the Care Chemicals business and technology personnel, Quality Managers, as well as Global Product Stewardship & Regulatory Affairs colleagues, Trade Associations, and/or NGOs. • Develop and document business-specific PSRA objectives and strategies aligned with the overall business strategy.
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Influences management/senior management decisions and is viewed as the Subject Matter Expert on CS decisions impacting a program and potentially the Medical/Scientific Affairs groups. In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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Represents Regulatory Affairs precision medicine subject matter expertise on cross-functional/cross-regional Regulatory Teams and other Sub-teams involved with the development and validation of IVDs (e.g., Study Management, Clinical, Biomarkers) and presents to senior leadership as required.
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The Analyst II, Regulatory Affairs has experience with and performs key centralized complex and difficult regulatory activities for the Compliance Department. Candidate must have knowledge of and experience with state and Federal regulatory and other requirements and practices related to Covered California, Medicare and Medi-Cal (Medicaid), Title 19 (USC)/Title 29 (USC and CCR), Title 22 (CCR), Title 28 (CCR), Title 42 (USC and CFR), CA Welfare and Institutions Code, and CA Health and Safety Code.
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Regulatory Affairs Specialist III (Current Employee) Hercules, CA. The Senior PCR Production Chemist responsible for the fermentation, purification, and formulation of materials used in PCR Production.
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senior manager regulatory affairs jobs Company: Abbvie in Beech-grove, Indiana
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