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Functional knowledge of Pricing & Reimbursement, Outcomes Research, Government Affairs, Corporate & Business Communications, Regulatory Affairs, Payer Management. Understanding of regulatory policies and impact of public relations within US.
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Reports to the Integrated TA Strategy Lead. Collaborates closely with cross-functional teams, including sales, marketing, medical affairs, market access and policy/advocacy (MAPA), regulatory affairs, and other relevant NNI departments to ensure alignment of brand objectives, strategies, and marketing promotion.
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Responsible for upholding regulatory and welfare standards as they pertain to laboratory animal care, husbandry, facilities, and the overall animal macro environment. Must have a solid foundation in the care and maintenance of USDA (Animal Welfare Act) regulated species as well as the regulatory requirements for maintaining those animals.
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Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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Extensive, relevant experience with expertise in ICT with hands on experience in several of the following areas: Commercial Analytics (Analytical Modeling, Forecasting and Pharmaceutical Market Research Data Sources); Research & Development, Pharmacovigilance / Quality Assurance / Regulatory Affairs, Supply Chain/Manufacturing/ERP and other corporate functions are preferred.
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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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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Contribution to global Medical & Scientific Affairs strategy in conjunction with Directors of EMEA and APAC Medical Affairs.
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Strong business acumen and ability to see the business drivers outside of Regulatory Affairs. Hands-on experience in preparing regulatory submissions during development and for marketing authorizations.
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Rocket Pharma is seeking an accomplished and strategic Senior Director of Regulatory CMC to lead our Chemistry, Manufacturing, and Controls (CMC) regulatory affairs. The ideal candidate will possess extensive experience in CMC regulatory affairs, particularly in writing CMC sections for INDs, NDAs, BLAs, and MAAs, as well as strong leadership skills.
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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Director, Regulatory Affairs Strategy Apply locations Princeton, NJ time type Full time posted on Posted 3 Days Ago job requisition id R10256.
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Ensures appropriate controls are in place to meet regulatory requirements (i.e. J-sox, Third Party Risk Management, etc) but also to ensure best practices in Sourcing. Specific experience in leading large, complex sourcing projects and supporting Senior Leadership on development of the sourcing strategy, management of risks and issues and the execution of the project to deliver the greatest value for money for the organization.
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Experience with CERCLA, RCRA, Brownfields and Voluntary regulatory programs, including local state regulatory programs. Preparation and editing of technical and regulatory reports.
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Reporting to the Senior/Executive Director or Vice President of Regulatory Affairs, the Director of Regulatory Affairs – CMC and Compliance will be responsible preparing CMC regulatory strategies that enable first pass approvals.
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Reporting directly to the Sr. Director, Global Medical & Scientific Affairs (GMSA), Abbott Point of Care. The Director of Medical Affairs, Americas oversees the day-to-day running of, and strategic leadership for, the Medical Sciences Liaison (MSL) team, as well as representing Medical Affairs internally & externally.
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regulatory affairs jobs Title: regulatory project manager Company: Gpac in Princeton, NJ
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