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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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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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Coordinate with business leaders and government affairs team on regulatory and legislative communications at the local, state, and federal levels. The Manager will drive strategic communications and community affairs initiatives to advance the business objectives of OxyChem, a subsidiary of Occidental (Oxy), primarily in New Jersey.
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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.
$190,625 a yearFull-timeExpandApply NowActive JobUpdated 3 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. Contribution to global Medical & Scientific Affairs strategy in conjunction with Directors of EMEA and APAC Medical Affairs.
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Sales Clinical Training: Work with the Head of Scientific Affairs and the Sales Directors to identify and address training needs to improve the team's clinical knowledge. Scientific Collaborations: Collaborate with key opinion leaders under the leadership of the North America Head of Medical Affairs to engage in important discussions related to medical/clinical, health economics, and outcomes research.
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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 13 days ago - UpvoteDownvoteShare Job
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Associate Director/Senior Manager, Global Regulatory Affairs Project Lead At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.
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Bachelor's degree in a scientific discipline and a minimum of 12+ years of Regulatory Affairs experience with progressive leadership responsibilities in a pharmaceutical, biotechnology or related environment (including a minimum of 7 years in Regulatory CMC role.
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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.
$203,550 a yearFull-timeExpandApply NowActive JobUpdated 9 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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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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regulatory affairs jobs Title: regulatory project manager in Lawrence, NJ
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