Global Regulatory Strategy Director
Daiichi Sankyo US
Daiichi Sankyo US in New Jersey seeks a Global Regulatory Lead to shape regulatory strategy for development programs and represent regulatory in GPT meetings. You will guide submissions, align regional plans, and ensure Health Authority alignment across global programs. Required: 7+ years in regulatory affairs with NDA/BLA experience including the US, and strong cross‑functional leadership in oncology-focused development. Travel up to 20%. #J-18808-Ljbffr Daiichi Sankyo US
- AbbVie in Florham Park, NJ is seeking a Director Regulatory Affairs Global Regulatory Lead to develop and implement global regulatory strategies across product life cycles. You will lead the GRPT, coordinate with LRST and AST, and drive regulatory excellence in a complex...Suggested
$182k
...@abbvie on LinkedIn, ( Facebook, Instagram ( , X ( and YouTube. ( Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market...SuggestedLocal areaWorldwide$193.04k - $289.56k
...Guided by our 2030 vision to "be an innovative global healthcare company contributing to the... ...families, and society.Job SummaryThe Global Regulatory Lead (GRL) is responsible for leading and developing global regulatory strategy for assigned development projects. The GRL...Suggested$184.24k - $276.36k
Initial Therapeutics, Inc. is seeking a Director, PV QA DSI to lead the Quality Assurance strategy within Clinical Safety and Pharmacovigilance (CSPV). This role... ...PV QA activities, ensuring compliance with regulatory requirements while leading a high-performing team....Suggested- ...Johnson & Johnson seeks a Director, Global Medical Affairs Strategy & Execution in Raritan, NJ. You will partner with GMAL to own strategy, generate integrated evidence plans, and lead publications across designated therapeutic areas. This role requires significant...Suggested
- ...than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainableFull time
- Merck & Co. is looking for a Senior Director, Clinical Safety Science, to shape and advance global safety strategy throughout the product lifecycle. This leadership role oversees a team of Safety Scientists, ensuring proactive safety surveillance and risk mitigation. The...
- AbbVie in Florham Park, NJ seeks a Director of Health Economics & Outcomes Research (HEOR... ...commercialization teams, accountable for HEOR strategies and delivery for at least one asset or... ...reports and will collaborate with global teams, communicating findings to internal...
$242.7k - $404.5k
Daiichi Sankyo US is looking for a Senior Director, Clinical Safety Science to lead global safety strategy across the product lifecycle. This key role oversees a team of Safety Scientists and collaborates with various stakeholders for proactive safety surveillance and...- Pacira BioSciences, Inc. is seeking an Associate Director of Regulatory Operations to drive global regulatory strategy and lead submission planning across regions. The role focuses on optimizing processes, ensuring timelines, and leveraging Veeva RIM as a SME to enhance...
$150k - $258.75k
...Raritan, New Jersey, United States of AmericaJob Description:Johnson & Johnson Innovative Medicine's Global Commercial Strategy Organizationis recruiting for a Director, Global Portfolio Strategy & New Business Developmentlocated in Raritan, NJ. About Innovative MedicineOur...Full timeLocal areaImmediate start$164k - $282.9k
...more at We are searching for the best talent for the Director, Global Medical Affairs Strategy & Execution (Oncology) to be based in Raritan, NJ.Position... ...scientists, global and regional marketing directors, regulatory leaders, outcomes research and statisticians. External...Full timeLocal areaImmediate startWorldwide$174.1k - $287.27k
...this roleThe OpportunityThis is a unique opportunity to build and lead the Global Planning Centre of Excellence (COE) for North America and Latin America. You will define the global planning strategy, governance, and operating model while driving the adoption and...Full timeWork at officeRelocation package- Johnson & Johnson is seeking a Director, Global Portfolio Strategy & New Business Development in Raritan, NJ. The role leads cross-functional portfolio planning, governance, and executive narratives across Innovative Medicine. You will partner with senior leaders to drive...
- Johnson & Johnson seeks an Associate Director, Alliance & External Affairs to lead strategic alliances... ...licensing, and integrations, coordinating with global partners to deliver on business needs while ensuring regulatory compliance. Travel up to 10% may be required. The...Work at office
- Daiichi Sankyo US is seeking a Director to lead the PMOBE within CSPV, shaping portfolio strategy, governance, and performance management. You will partner with senior... ...to improve efficiency and outcomes across global initiatives. #J-18808-Ljbffr Daiichi Sankyo US
- Pacira BioSciences, Inc. seeks a regulatory affairs leader to manage complex projects and guide strategic decisions. With a focus on non-opioid pain management, you will oversee regulatory submissions and collaborate cross-functionally. The ideal candidate has 10+ years...Flexible hours
- ...development company based in New Jersey is seeking a professional in Global Medical Affairs. This role requires accountability for... ...scientific leaders to develop sound medical rationale and support regulatory submissions. Join us to make a significant impact in the medical...
$260k - $295k
Overview Join to apply for the Senior Director, Global Commercial Strategy role at Shionogi Inc. (U.S.) . The Senior Director, Global Commercial Lead... ...payer/reimbursement, health outcomes, clinical, regulatory, and project management. Accountable for ensuring patient...Full timeWork at officeLocal area2 days per week3 days per week- ...Instagram, X and YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development... ...the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the...
- ...Solstice Mobile, Inc. is seeking a General Manager to oversee the Hydrogen Fluoride segment and drive the global Strategic and Annual Operating Plans. This role, based in Morris Plains, NJ, requires significant travel and strong leadership skills. The ideal candidate...
- Daiichi Sankyo, Inc. seeks a Director to lead the PMOBE function within CSPV, guiding the end-to-end delivery of global, cross-functional programs aligned to enterprise priorities. You will partner with senior leaders to shape strategic priorities and drive measurable...
$150k - $200k
...Every essence of you enriches our world. We are Givaudan. Human by nature.Join us as our next Head of Systems Strategy - Regulatory, reporting to our Global Head of Regulatory Compliance & Digital Strategy. We are looking for an experienced Solution Lead with a track...$128.6k - $210k
...Manager, Regulatory Affairs Strategy Oncology At Regeneron, we use science and innovation to develop life-changing medicines for people with... ...team. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in...Worldwide$117k - $201.25k
...Clinical/Clinical DevelopmentJob Sub Function: Regulatory ScienceJob Category:Scientific/... ...talent for Principal Scientist (Manager), Global Regulatory Affairs, CMC.Purpose: The Principal... ...for developing global CMC regulatory strategies and dossier content plans according to...Full timeLocal areaImmediate start- ...and knowledge in drug manufacturing and QA compliance. This position is poised for impact in a collaborative environment, supporting global operations with potential travel requirements up to 30%. A Bachelor's degree in a scientific field is essential, while a Master's...Contract work
- ...of experience in Quality Assurance within a large pharmaceutical organization, extensive audit readiness, and expertise in managing global teams. The position also offers significant influence in promoting a culture of continuous improvement. #J-18808-Ljbffr Initial...Contract work
$150k - $180k
...for you based in Florham Park, NJ. The Global Trade Compliance Director role offers a highly visible opportunity to lead global compliance strategy across the Fluid and Motion Control... ...for all FLMC locations. Participate in Regulatory Compliance strategic projects, teams...Local area$127.28k - $190.92k
...by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable... ...on business performance. Works with Director of FP&A to streamline and improve... ...effective approaches that are aligned to our strategy. Change Management & Special Projects:...- Roche in New Jersey seeks an experienced Regulatory Affairs professional to support global medical diagnostic products. The role involves registering and addressing affiliate questions, improving processes with RPA, and ensuring regulatory compliance across US and international...
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