Global Regulatory Affairs Labeling Expert

Job DetailsJoin a Legacy of InnovationDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more...

Job Title: Associate Director, Labeling ExpertJob Summary:We are seeking an experienced Associate Director, Labeling Expert to join our Global Regulatory Affairs team. The successful candidate will be responsible for providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This role will manage...

Job DetailsTransforming Healthcare through Innovative Regulatory StrategiesDaiichi Sankyo Group is dedicated to creating and supplying innovative pharmaceutical therapies to improve healthcare standards and address unmet medical needs globally. With a rich legacy of scientific expertise and a presence in over 20 countries, Daiichi Sankyo and its 16,000...

Unlock Your Potential in Regulatory AffairsDaiichi Sankyo, Inc. is a global pharmaceutical innovator with a rich legacy of innovation and a robust pipeline of promising new medicines. We are seeking a highly skilled Regulatory Affairs Director to join our team and contribute to our mission of delivering innovative treatments for patients with cancer.Key...

Job SummaryThe Senior Manager CMC Regulatory Affairs will lead the regulatory strategies for biologic products and combination products for the product portfolio assigned.Key ResponsibilitiesResponsible for CMC/CP product development activitiesRegulatory Affairs, Manager, Regulatory, Senior, Communications, Product Development, Business ServicesWhat You'll...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at Regeneron Pharmaceuticals. As a key member of our regulatory affairs team, you will be responsible for providing leadership on global regulatory activities for our assigned products.Key ResponsibilitiesProvide interpretation of regulatory authorities' feedback,...

Job SummaryThis role offers the opportunity to contribute to the mission of Daiichi Sankyo in leveraging innovative science and pushing beyond traditional thinking to create meaningful treatments for patients with cancer. The successful candidate will work on one of our cutting-edge assets by effectively liaising, negotiating, and partnering with FDA. This...

Job SummaryWe are seeking a highly experienced Senior Manager CMC Regulatory Affairs to lead our regulatory strategies for biologic products and combination products.Key ResponsibilitiesDevelop and implement regulatory strategies for assigned product portfolioLead CMC/CP product development activities in Regulatory AffairsCollaborate with cross-functional...

Job SummaryWe are seeking a highly skilled Business Systems Analyst to join our team at Insight Global. As a Business Systems Analyst, you will play a critical role in supporting the delivery of GxP validated global business systems serving cross-functional stakeholders.Key ResponsibilitiesPartner with business stakeholders to architect and implement...

Join a Legacy of InnovationDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.About Daiichi SankyoWith more than 100 years of scientific expertise and a presence in...

Lead US Oncology Medical Affairs StrategyDaiichi Sankyo is seeking a seasoned medical affairs professional to lead the US oncology medical affairs strategy for our assigned compound. As a key member of the US Oncology Medical Affairs team, you will develop and execute the US medical affairs plan, including launch readiness and life cycle management...

US Oncology Medical Affairs Director OpportunityWe are seeking a highly experienced and skilled US Oncology Medical Affairs Director to lead our efforts in the US market. As a key member of our US Oncology Medical Affairs team, you will be responsible for developing and executing the US Medical Affairs strategy and plan for our assigned compound.Key...

US Oncology Medical Affairs Director - Therapeutic Area LeadCompany OverviewDaiichi Sankyo is a global pharmaceutical innovator with a rich legacy of innovation and a robust pipeline of promising new medicines. Our 2025 Vision is to become a "Global Pharma Innovator with Competitive Advantage in Oncology."Job SummaryWe are seeking a highly experienced US...

About the RoleWe are seeking a highly skilled Clinical Document Reviewer to join our team at PSG Global Solutions Careers. As a Clinical Document Reviewer, you will play a critical role in ensuring the quality and compliance of clinical documents in our eTMF system.Key ResponsibilitiesReview clinical documents for quality and compliance in our eTMF system,...

Transforming Innovation into Patient ValueDaiichi Sankyo, Inc. is a global pharmaceutical innovator dedicated to delivering cutting-edge therapies that improve patient outcomes and address unmet medical needs. With a rich legacy of scientific expertise and a robust pipeline of promising new medicines, we are committed to transforming next-generation science...

Job SummaryThe Associate Director of Regulatory Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position requires collaboration across various functions to meet aggressive timelines.ResponsibilitiesWrite critical, complex clinical and clinical...

Job SummaryWe are seeking a highly skilled and experienced professional to join our team as a Director of State Government Affairs. This role will be responsible for leading our engagement across the United States to ensure patient access to our current portfolio and robust pipeline of medicines.Key ResponsibilitiesDevelop, lead, and prioritize Daiichi...

Job SummaryWe are seeking a highly experienced Clinical Science Group Lead to join our team at Daiichi Sankyo, Inc. This is a critical role that will lead the development of our late-stage clinical studies and ensure the highest scientific and medical standards are met.Key ResponsibilitiesDevelop and execute the global clinical science strategy for...

Job SummaryThe Associate Director, Companion Diagnostics Lead will play a key role in guiding the strategy and leading the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. This position will contribute to CDx project teams, providing scientific and technical expertise to...

About the RoleWe are seeking a highly skilled and experienced Director, Informatics to join our team at Daiichi Sankyo, Inc. as a key member of our Research and Development (R&D) organization.Key ResponsibilitiesInformatics Systems Development and ImplementationDevelop and implement R&D informatics systems and programs to support business functions,...