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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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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.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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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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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.
$190,625 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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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.
$190,625 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Reporting directly to the Sr. Director, Global Medical & Scientific Affairs (GMSA), Abbott Point of Care.
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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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Support for the Sr. Director of GMSA, including representing Medical Affairs & the company at professional medical congresses and/or stakeholder groups as required by the function. Contribution to global Medical & Scientific Affairs strategy in conjunction with Directors of EMEA and APAC Medical Affairs.
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Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
$286,700 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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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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The Product Director must work closely with multiple functions including Sales, Sales Learning & Development, Commercial Insights & Strategy, Medical Affairs, Global Strategic Marketing, Communications, Regulatory, Health Care Compliance (HCC), Innovative Medicine affiliates, outside vendors, and Key Opinion Leader speakers to effectively implement key commercial activities.
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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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Discuss strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development. As an Associate Director, Biostatistician, you will be a champion of Otsuka’s culture and values and will be responsible for providing statistical expertise/input in the drug development, including clinical development plan and regulatory submission strategy.
Full-timeExpandApply NowActive JobUpdated 30 days ago
regulatory affairs jobs Title: sr regulatory associate Company: Thermo Fisher Scientific in Princeton, NJ
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