Global Regulatory Submissions Lead
BioSpace
Sanofi in Morristown, NJ invites a Global Submission Lead to plan, coordinate, and track regulatory submissions for global programs. You will ensure compliance with ICH guidelines, manage submission plans, and mentor GRO peers in dossier processes. The role requires cross-cultural collaboration, strong communication, and extensive experience in regulatory operations. Travel may be required to support global regulatory activities. #J-18808-Ljbffr BioSpace
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory Submissions Lead in Convent Station, NJ vacancy
- ...Location: Morristown, NJ / Cambridge, MA. Job title: Global Submission Lead About The Job As Global Submission Lead within our R&D team, you... ...responsible for the planning, coordination, and tracking of regulatory Priority portfolio and Integration submission activities for...RegulatoryWorldwideFlexible hours
- ...Senior Manager/Associate Director of Regulatory Affairs CMC to define and execute global CMC regulatory strategies for... ...supply and program teams to deliver submission-ready CMC content with a risk-... ...approach. Responsibilities include leading global CMC strategies,...Regulatory
- Perrigo Company plc is seeking a Vice President, Head of Regulatory Affairs - Cluster to lead the Global Cluster Regulatory organisation and drive in‑market... ...activities across categories, ensuring timely, high-quality submissions and #J-18808-Ljbffr Perrigo Company plcRegulatory
- Net2Source (N2S) seeks a Global Regulatory CMC Manager (Senior Consultant) to lead global CMC regulatory activities across clinical and commercial products. You... ...will shape regulatory strategies, prepare global submissions, and collaborate with cross-functional teams to...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
- ...provide timely, accurate information for assigned therapeutic areas. You will develop and maintain global content, review complex medical data, and ensure compliance with regulatory standards. The role requires deep product knowledge, strong communication, and the ability to...Regulatory
- AbbVie seeks a Director Regulatory Affairs Global Regulatory Lead to develop and implement global strategies ensuring market approvals and lifecycle management for assigned products. You will lead the Global Regulatory Product Team and coordinate with AST and LRST to align...Regulatory
- ...Statistical Programmer in East Hanover, NJ. You will lead a team of programmers across global clinical programs, driving efficiency, quality, and... ..., Data Management, and clinical teams to support regulatory submissions and decision making, with a focus #J-18808-Ljbffr...Regulatory
- ...team for Lifecycle Management. You will drive regulatory strategy across the product lifecycle, manage... ...to FDA standards, and ensure timely, compliant submissions that support supply, safety, and market access. You will lead complex post-approval changes, renewals, and mid...Regulatory
- ...activities, drive continual improvement, and coordinate with digital teams on new systems while ensuring regulatory compliance across US and EU markets. You will partner with Global Safety Officers and PV Scientists to monitor product safety throughout the lifecycle and help...Regulatory
- Opella is seeking a Global HCP Lead for Allegra in Morristown, NJ. You will shape the global HCP marketing strategy, develop assets for... ...worldwide impact. You will collaborate with Brand, Medical, and Regulatory teams to ensure accuracy, compliance and effective content...RegulatoryWorldwide
- Sanofi is seeking a Global Brand Lead for Transplant (Solid Organ Transplant) to drive end-to-end strategy across the SOT portfolio. The role... ...Medical Affairs, Market Access, Corporate Affairs, Digital, Regulatory, and regional commercial teams. #J-18808-Ljbffr BioSpaceRegulatory
- Sanofi in Morristown, NJ (hybrid) seeks a GRA Global AdPromo Excellence Lead to balance regulatory review of promotional materials with cross-functional excellence initiatives, leveraging AI-driven tools to improve efficiency. The role supports global ads/promo governance...RegulatoryWorldwide
- Sanofi is seeking a Global Brand Lead for Transplant (Solid Organ) in Morristown, NJ and Cambridge, MA. This senior role leads end-to-end... ...collaborate with Medical Affairs, Market Access, Digital and Regulatory, report to SVP, and drive cross-functional execution, ensuring...Regulatory
- ...Executive Director, Value Chain Management Lead (VCL) to drive end-to-end value chain... ...products and pipeline assets. You will lead Global Operations teams, integrating development, manufacturing, supply chain, quality, regulatory, and finance into strategic decisions....Regulatory
- Job Title: Global Brand Lead, Transplant (Solid Organ Transplant) Location: Morristown, NJ, Cambridge, MA About The Job Sanofi is a global... ...Medical Affairs, Market Access, Corporate Affairs, Digital, Regulatory, and regional commercial teams. Main Responsibilities A critical...RegulatoryLocal areaShift work
- Job title: Global Periodic Reporting lead Location: Cambridge, MA / Morristown, NJ / Swiftwater, PA About the Job Join the engine of Sanofi’s mission... ...(PSR) authoring and vendor oversight while upholding regulatory compliance expectation Lead the Periodic Report Expert (...RegulatoryWorldwide
- Global Lead, Innovation Expansion & Adoption Location: Cambridge, MA, Morristown, NJ About The Job At Sanofi, we chase the miracles of... ...scaling strategies are adapted for local market contexts, regulatory requirements, and operational capabilities. Develop Hub‑specific...RegulatoryPermanent employmentLocal areaWorldwide
- Job Title Global Lead, Scientific Platforms & Engagement Strategy Location: Cambridge, MA; Morristown, NJ About the Job At Sanofi, we... ...all scientific platforms and AI‑generated content meet regulatory, medical‑legal‑regulatory review, and ethical standards applicable...Regulatory
- Job title : Global Lead, Health Ecosystem & Innovation Location: Cambridge, MA, Morristown, NJ About The Job At Sanofi, we chase the... ...environment. Stay current on the evolving digital therapeutics regulatory landscape, patient data governance standards, and start‑up...Regulatory
$254.53k - $308.43k
...scientifically deployable for the MEG, MAP & RWE and Global Medical teams. Specifically, the role... .... Responsibilities Build & Lead the RWD Innovation Center Establish... ...propensity methods, eligibility alignment, and regulatory considerations Hybrid designs:...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Job title : GRA Global AdPromo Excellence Lead Location: Morristown, NJ - Cambridge, MA About the job A hybrid role combining support for global promotional material regulatory review (30%) with transversal excellence activities (70%). The position supports innovation,...RegulatoryWork at officeLocal areaWorldwide
- A leading staffing firm is seeking a Medical Author to document clinical data and regulatory submissions to support drug development. This role requires expertise in analytical writing, project management, and collaboration with product teams to ensure high-quality deliverables...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- Sanofi is seeking a Global Periodic Reporting Lead to drive PSR authoring, global PSR planning, and vendor oversight across the portfolio. The role... ...staff, and shapes outsourcing strategies to ensure regulatory compliance and continuous process improvement. The candidate...Regulatory
- ...in Morristown, NJ seeks a senior leader to build and govern the global customs and trade compliance framework, aligning with financial... ...duty spend, and push continuous improvement while ensuring regulatory readiness and risk mitigation. #J-18808-Ljbffr Schindler GroupRegulatory
- ...oversee the Americas FLMC Trade Compliance program, directing a global team of professionals and ensuring export, import, and supply... ...security compliance. The role requires experience in multinational regulatory environments, knowledge of USMCA, and the ability to interact...Regulatory
- ...Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins is... ...Area and supports manager and/or Global Regulatory Lead (GRL) in the development... ...and review of regulatory submissions consistent within US and Canada regulatory...RegulatoryFull timeLocal area
- ...Officer to drive privacy strategy across global R&D and medical programs. You will... ...culture of privacy, and work with legal, regulatory, and government affairs to protect patient... ...regulators and industry standards while leading responses to audits and inspections. #J...Regulatory
- ...Therapeutics, Inc. seeks a seasoned Head of Global Biostatistics & Data Management to set... ...to life cycle management. You will lead a global team, ensure timely, high-quality... ...to shape development strategies and regulatory submissions in oncology programs. #J-18808-Ljbffr...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Submissions Lead. Be the first to apply!
Related searches
- food regulatory Convent Station, NJ
- regulatory contract Convent Station, NJ
- regulatory cmc Convent Station, NJ
- regulatory Convent Station, NJ
- regulatory scientist Convent Station, NJ
- regulatory law Convent Station, NJ
- clinical research regulatory Convent Station, NJ
- nutrition regulatory
- food regulatory
- scientific regulatory


