Global Regulatory Strategist — Lead HA Strategy & Submissions
BioSpace
Sanofi Inc. in Morristown, NJ and Cambridge, MA is seeking a Regulatory Strategist to shape global regulatory strategy for assigned projects, including Health Authority interactions, across US, EU, and international programs. As a key member of the Global Regulatory Team (GRT), you will provide regulatory input, lead briefing documents, manage timelines, and coordinate submissions (NDA/BLA/MAA, IND/CTA) with cross‑functional partners. #J-18808-Ljbffr BioSpace
- Sanofi is seeking a Regulatory Strategist to lead the development and execution of regulatory strategies in Morristown, NJ. You will work within the R&D team to support submissions and ensure compliance with US, EU, and global requirements. The ideal candidate has a scientific...RegulatoryFull time
- Sanofi in Morristown, NJ seeks a Global Submission Manager to oversee global regulatory submissions within the GRA portfolio. You will coordinate with Global Regulatory Teams, Submission Leads, and cross‑functional colleagues to plan, execute submissions in alignment with...Regulatory
- Sanofi is seeking a Global Submission Manager in Morristown, NJ to manage all submission types for the GRA portfolio. The role includes representing GRO on Global Regulatory Teams, prioritizing workload, and negotiating timelines with stakeholders. Close collaboration with...Regulatory
- ...seeking a (Sr.) Director of Regulatory Affairs to establish and lead the Regulatory Affairs... ...role involves supporting the global product team in developing registration strategies for product approvals in... ...leveraging their expertise, manage submissions, and develop timelines in...Regulatory
- Global Regulatory Strategist Job title: Global Regulatory Strategist Location... ...regulatory product strategies for the oncology therapeutic area, leading regulatory efforts in... .... Health Authority (HA) Engagement... ...as needed. Regulatory Submissions & Operations Leads submission...RegulatoryLocal area
- About the job As the Global Regulatory Lead on our Global Regulatory... ...global regulatory strategies for their products in... ...Strategy (GRPS), Global Submission Strategy, and core... ...a team of Regulatory Strategists (RS) as appropriate.... ...development of global HA interaction plan and...Regulatory
- BioSpace is hiring a GRA CMC Lead in Morristown, NJ. In this role, you will manage CMC regulatory strategies and work closely with health authorities, ensuring compliance... ...regulatory experience, and the ability to navigate global regulations. The position offers a...Regulatory
- Sanofi is seeking a Global Regulatory Lead in Morristown, NJ, responsible for developing and executing global regulatory strategies for oncology products. Candidates should have significant regulatory affairs experience along with investigative and strategic thinking skills...Regulatory
- EmergencyMD is seeking a regulatory CMC specialist to provide global regulatory support throughout the product lifecycle in Morristown, New Jersey. The role involves managing high-quality CMC regulatory submissions and ensuring timely execution of corporate goals. The ideal...Regulatory
- Eacademy Sanofi in Morristown, NJ is seeking a GRA CMC Lead to manage regulatory strategies for the R&D team. This role involves direct interaction with... ...sector. Join our innovative team to bring life-changing medicines to patients globally. #J-18808-Ljbffr Eacademy SanofiRegulatory
- Sanofi in Morristown, NJ seeks a Platform Lead for Regulatory Strategy and Continuous Improvement, coordinating cross-functional programs across global regulatory landscapes in CMC and device areas. You will establish global responsibilities, build governance structures...Regulatory
- Sanofi Morristown seeks a Regulatory Strategy & Continuous Improvement - Platform Lead to steer global CMC/Device regulatory activities. You will lead multiple cross-functional programs, align project objectives with strategy, and drive change management across interconnected...Regulatory
- A leading software development company based in New Jersey is seeking a professional in Global Medical Affairs. This role requires accountability for deliverables, including... ...sound medical rationale and support regulatory submissions. Join us to make a significant impact...Regulatory
- ...Morristown, NJ and Cambridge, MA, is seeking a Global Regulatory Strategist to drive regulatory product strategies in oncology. You will lead cross‑functional teams, develop... ...Health Authorities, and oversee regulatory submissions and expedited pathways to support timely...Regulatory
$150k - $180k
Emerson in Florham Park, NJ, is looking for a Global Trade Compliance Director to lead regulatory and compliance strategies across their Fluid and Motion Control businesses. This role requires strong leadership in managing trade compliance and developing effective international...Regulatory- ...Manager/Associate Director of Regulatory Affairs CMC to define and execute global CMC regulatory strategies for assigned assets. The... ...and program teams to deliver submission-ready CMC content with a risk... ...approach. Responsibilities include leading global CMC strategies,...Regulatory
- ...in Morristown, NJ. In this role, you will contribute to global regulatory strategies for medical device and combination products, collaborating... ...landscapes. The role includes preparing high-quality regulatory submissions and supporting compliance activities. Join us to make a...RegulatoryWorldwide
$127k - $170.5k
...products to consumers worldwide. Serve as a Global Regulatory CMC Lead within the Global Regulatory CMC Team... ...teams to support regulatory strategy and execution. Maintain compliance while... ...timelines Manage regulatory submissions across major markets (FDA, EU, etc.)...RegulatoryWorldwide$148.5k - $214.5k
Job Title Regulatory Strategist Location Morristown, NJ / Cambridge, MA... ...by defining and executing global regulatory strategies for assigned projects. You... ...regulatory requirements, lead Health Authority (HA) interactions, and support submissions such as NDA/BLA/MAA, IND/...RegulatoryFull timeLocal area- Job title: Regulatory Strategist Location: Morristown,... ...key member of the Global Regulatory Team (... ...Global Regulatory Lead (GRL), you will... ...global regulatory strategy and drive the execution... ...Authority (HA) interactions. You... .... Leads submission team or regulatory...RegulatoryLocal area
$150k - $200k
Givaudan Fragrances in East Hanover, NJ, is seeking a Head of Regulatory Systems Strategy to lead compliance innovation within the Fragrance & Beauty divisions. This role requires an experienced professional to drive complex projects and facilitate cross-functional collaboration...Regulatory- Bristol Myers Squibb is seeking a Director, US Regulatory Lead to oversee regulatory strategy and execution for the Immunology and Cardiovascular therapeutic... ...manage Health Authority interactions and lead NDA submissions. With responsibilities that include providing...Regulatory
- Sanofi Inc. seeks a Regulatory Strategy & Continuous Improvement Platform Lead in Morristown, NJ. You will guide global regulatory activities, build governance structures, and drive cross-functional alignment across GRA CMC and GRA Device teams. You will manage multiple...Regulatory
$150.8k - $226.2k
..."be an innovative global healthcare company... ...implementation of the quality strategy closely aligned... ...late ICSR submission of reports, and... .... Ensure adequate regulatory inspection and audits... .../Audits. Lead in a proactive and... ...line with worldwide HA requirements are implemented...RegulatoryLocal areaWorldwide- Job Title Global Head of Clinical Data and Business Strategy Location Morristown, NJ or Cambridge, MA About The... ...clinical databases supporting regulatory submissions. We seek an exceptional leader... ...development and the proven ability to lead transformational change through...Regulatory
$148.5k - $214.5k
Job Title: Regulatory Strategy & Continuous Improvement - Platform Lead Location: Morristown, NJ Overview As the Platform Lead within our R&D team, you will spearhead... ...coordinating multiple concurrent programs across global regulatory landscapes. You will establish global...RegulatoryWorldwide- Daiichi Sankyo, Inc. is seeking an Executive Director for Oncology R&D, Global Clinical Lead, to oversee multi-program development and strategic regulatory submissions. The role drives clinical strategy, partners with CROs and senior management, and aligns development...Regulatory
$240.94k - $291.96k
...Position Director, US Regulatory Lead, GRS Position Summary The... ...will oversee regulatory strategy and execution for Immunology... ...Health Authority (HA) interactions along including upcoming NDA submission. The incumbent may also serve as Global Regulatory Lead (GRL)/USRL...RegulatoryFull timeTemporary workRemote work- .... seeks a senior clinical development leader to oversee global programs and lead regulatory strategy across multiple Phase II/III studies. You will ensure CRO performance and provide medical input into submissions, translational medicine, and biomarker plans. You will represent...Regulatory
- Job Title AI Enablement and Adoption Lead, Strategy and Operations, Specialty Care GBU Location... ...they use by habit. Reporting to the Global Head of Strategy & Operations,... ...new ways of working respect the GBU’s regulatory, privacy, data‑protection, and information...RegulatoryWork at office3 days per week
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