Global Regulatory Submissions Strategy Director
Scorpion Therapeutics
Scorpion Therapeutics is seeking a Director of Global Submission Management to provide strategic oversight and execution of a portfolio of regulatory submissions across development and lifecycle programs. You will lead submission planning, timelines, and cross-functional collaboration to ensure timely, compliant registrations across global programs and markets. The role emphasizes staff leadership, process standardization, and the integration of emerging technologies to optimize submissions. #J-18808-Ljbffr Scorpion Therapeutics
- Scorpion Therapeutics seeks an Associate Director, Global Submission Management to orchestrate global regulatory submissions across development and lifecycle programs... ...or Cell & Gene Therapy areas and partners with Strategy, CMC, Labeling, Publishing, and Advertising & Promotion...Regulatory
- ...States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance... ...This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes...Regulatory
- Treeline Biosciences in Watertown, MA is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities, shape strategy, and manage submissions across INDs, NDAs, and BLAs. The role requires 8+ years in regulatory affairs...Regulatory
- ...Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This... ...developing and executing regulatory strategies to support global product development, particularly... ...the ability to manage regulatory submissions and work with health authorities such...Regulatory
- Beeline Medicines in Boston is seeking a Director, Regulatory Strategy - Global Regulatory Lead to shape integrated global regulatory plans for early... ..., CMC, Non‑Clinical Sciences, and Bioanalytics to drive IND/CTA and NDA/BLA submissions, #J-18808-Ljbffr BioSpaceRegulatory
- Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy and overseeing all regulatory activities for high... ...teams to ensure timely and quality submissions to the FDA and other agencies....Regulatory
- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead global regulatory plans for assigned programs in rare, autoimmune and oncology portfolios... ...with Regulatory Science and Project teams to manage submissions, monitor regulatory intelligence, and lead process...Regulatory
- .... in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality... ...deliverables. You will support global filing strategies, coordinate with Global Regulatory Affairs... ...Quality, and ensure timely, compliant submissions across development, commercialization...Regulatory
- Kailera Therapeutics seeks an Associate Director, Global Regulatory Affairs to lead day-to-day regulatory activities for early and late-phase investigational products, guiding IND/CTA submissions and future marketing applications, and advising cross-functional teams on...Regulatory3 days per week
$145k - $185k
A biotechnology company is seeking a highly motivated Senior Manager for Regulatory Affairs Operations. This role involves overseeing regulatory submissions and managing compliance with global standards. Candidates should have a solid understanding of the pharmaceutical...RegulatoryRemote job- Beeline Medicines in Boston is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for assigned programs. This role reports to the... ...& Quality and will manage global regulatory submissions (IND/CTA/NDA/MAA) and interactions with health authorities...RegulatoryWorldwide
- A leading biotechnology company in Boston is seeking a Senior Manager for Regulatory Affairs Operations. In this hybrid role, you will lead global regulatory submissions and collaborate across teams to ensure timely delivery of regulatory documents. The ideal candidate...Regulatory
- Vertex Pharmaceuticals is seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across development and... .... You will partner with Global Regulatory Strategy, CMC, Labeling, Publishing, and Advertising...Regulatory
- Parabilis is seeking a Senior Manager/Associate Director, Regulatory Operations to drive regulatory success and shape development of life-changing treatments. You will lead global regulatory submissions, information management, publishing, and Health Authority interactions...Regulatory
$196.7k - $353.4k
...seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will... ...development through commercializationDrive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and urgencyLead health...RegulatoryPermanent employmentFull timeWork at officeWork from home$196.7k - $353.4k
...Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be... ...to articulate clear and compelling global regulatory strategies, highlighting... ...format and accountability for regulatory submissions and related supplements and...RegulatoryPermanent employmentFull timeWork at officeWork from home$200k - $265k
...opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab across all approved and development-stage indications,...RegulatoryFull timeTemporary workWork experience placementWork at officeWorldwide- ...seeks a senior leader to drive its Real World Evidence (RWE) strategy for the Global Rare Diseases (GRD) Hematology, Immunology, Dermatology... ...plans, partner with cross-functional teams, and influence regulatory and payer decisions from Boston in a hybrid setting. The role...Regulatory
- ...Therapeutics in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-functionally to... ...oversee USPI/CCDS labeling, manage SPL submissions, and drive lifecycle labeling from development...RegulatoryWork at officeRelocation
- ...professional to join our labeling strategy team. This team is responsible... ...Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional... ...Operations and Supply Chain to ensure submission-ready labeling components comply...RegulatoryLocal area
- ...medical communications, review PRC and DSMR submissions, and ensure content consistency with our therapeutic strategy. You will coordinate with Legal/Compliance, Regulatory Affairs, and Commercial teams, align US content with the Global Medical Platform, and support cross-...Regulatory
- ...Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be... ...to articulate clear and compelling global regulatory strategies, highlighting... ...format and accountability for regulatory submissions and related supplements and...RegulatoryWork from home
- ...MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs... ...to ensure alignment between US and global strategies. Exceptional communication... ...successful FDA interactions and regulatory submissions. The role offers robust healthcare...Regulatory
- Takeda Pharmaceutical Company Limited in Boston, MA, is seeking an accomplished Regulatory CMC leader to drive global submissions and strategy across development and lifecycle, with strong leadership and communication skills. The role requires 10+ years in biopharmaceutical...Regulatory
- Alpha-9 Oncology is seeking an experienced Associate Director, Regulatory Affairs to join our Regulatory Affairs team and shape global regulatory strategy for our clinical pipeline. This hands-on leader will drive submission planning and interactions with health authorities...Regulatory
- ...hybrid work model, seeks an experienced Vice President of Regulatory Affairs to lead global strategy and agency interactions as deupirfenidone advances... ...reports to the Chief Medical Officer and will own submissions across programs, build scalable processes, and mentor...Regulatory
- Merida Biosciences in Cambridge, MA is seeking an Associate Director of Regulatory Operations to lead global submission planning and lifecycle management across development programs. This hands-on role drives document readiness, eCTD publishing, cross-functional coordination...Regulatory
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...I&I portfolio, encompassing pre-IND planning, IND/CTA submission strategy, Phase I/II/III development planning, and...RegulatoryLocal areaFlexible hours2 days per week- Scorpion Therapeutics seeks a Global Regulatory Lead to own global regulatory strategies from entry to lifecycle, providing strategic and technical leadership... ...the US FDA. The role includes overseeing US FDA submissions (INDs/NDAs/BLAs), shaping development plans, and...RegulatoryLocal areaRelocation package
- ...Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the... ...RNA technology in the US and other global markets. Responsibilities Serve as... ...global strategy, including for IND submissions. Lead the strategy for US FDA interactions...Regulatory
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