Global Submissions Strategy Director
Scorpion Therapeutics
Scorpion Therapeutics seeks an Associate Director, Global Submission Management to orchestrate global regulatory submissions across development and lifecycle programs. This role focuses on Pulmonary or Cell & Gene Therapy areas and partners with Strategy, CMC, Labeling, Publishing, and Advertising & Promotion to align milestones. The successful candidate will oversee multiple programs, manage risks, and ensure timely, compliant submissions while driving continuous improvement and staff #J-18808-Ljbffr Scorpion Therapeutics
- ...is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years of experience in drug development...Suggested
- ...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...Suggested
- ...pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic... .... The candidate will prepare regulatory submissions, interact with health authorities like... ...This role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema...Suggested
- 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... ...functional teams to ensure timely and quality submissions to the FDA and other agencies. Ideal candidates...Suggested
- ...Incorporated in Boston, MA, is seeking a Regulatory Strategy Associate Director to oversee the global regulatory strategy for development programs and marketed... ..., advising teams, and ensuring compliance of submissions. Vertex offers a hybrid work model and a comprehensive...Suggested
- ...Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston... ...developing and executing regulatory strategies to support global product development, particularly in... ...the ability to manage regulatory submissions and work with health authorities such...
- Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for multiple programs. The role oversees IND/CTA/NDA/MAA submissions, health authority interactions, and lifecycle management. Hybrid work with on-site days is expected...
- 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...
- 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 BioSpace
- Discover International is seeking an Associate Director or Director to lead Global Regulatory Affairs on an initial contract. You will drive regulatory strategy, lead FDA interactions and manage submissions for multiple development programs, with potential conversion to...Remote jobPermanent employmentContract work
$212k - $318k
...medicines to reach patients faster than ever before.The **Director, T1D** will serve as a **T1D Market Access Lead** within our **Cell and Gene Therapy (CGT)** portfolio in the **Global Value and Access Strategy (GVAS)** team.The individual will be responsible for leading...Summer workRemote workFlexible hours2 days per week$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...Permanent employmentFull timeWork at officeWork from home$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...Permanent 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,...Full timeTemporary workWork experience placementWork at officeWorldwide$212k - $333.19k
...empower you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid... ...Program(s). The GPL defines the asset strategy and leads all development and LCM projects... ...through large-scale Phase III/submission projects and global launch projects.Links...Minimum wageTemporary workWork at officeLocal areaRemote workNight shift$128.55k - $222.82k
...The Director, Global Wellbeing is a member of the Global Pension, Benefits and Wellbeing Team, and reports to the AVP, Global Benefits and... ...role develops and executes a comprehensive global wellbeing strategy that supports all facets of employees’ wellbeing, while advancing...Full timeTemporary workLocal areaFlexible hours- ...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...Work at officeRelocation
- AstraZeneca's Biopharmaceuticals Business Unit (BBU) is seeking a strategic marketer to drive brand strategy and launch readiness across global markets, including the USA. You will partner with Patient & Business Insight, Medical Affairs, R&D, Pricing & Market Access, Commercial...Local area
- SharkNinja in Needham, MA is seeking a Director of Media Strategy & Activation to lead global media strategy and execute full-funnel campaigns across NA, LATAM, Canada, and EMEA. You will own budgets, shape media briefs, and drive cross-functional partnerships to deliver...
- AbbVie in Boston seeks a Director, Health Economics & Outcomes Research (HEOR) to lead the development and execution of HEOR strategies for at least one asset or indication in US and/or international... ..., with strong leadership and global collaboration experience in the #J-18...
- MBX Biosciences is seeking a Director of Regulatory Affairs to lead global regulatory strategies for its clinical stage programs, including INDs and CTAs, in alignment... ...manage FDA/EMA interactions, and oversee regulatory submissions and #J-18808-Ljbffr MBX Biosciences, Inc.
- SharkNinja is seeking a Director of Media Strategy & Activation to lead global, data-driven media planning and execution across North America, Latin America, Canada, and EMEA. You will oversee top-of-funnel paid media investment, align with DTC, Retail, and Amazon teams...
- SharkNinja is seeking a Director, Media Strategy & Activation to lead development and execution of full-funnel, data-driven media strategies for... ...brand-building with short-term performance, overseeing global media budgets, and driving innovation across TV, streaming,...Temporary work
- Takeda is seeking a senior medical leader to drive the global medical strategy for zasocitinib in PsA. You will provide director-level guidance on product profile, data interpretation, and external scientific dynamics while coordinating a global medical team and matrix...
- Scorpion Therapeutics in Boston seeks a Senior Global Regulatory Leader to drive regulatory strategy across oncology programs from discovery through late-stage... ...accelerate patient access. You will manage US FDA submissions (NDA/BLA/MAA) and liaise with global regulators,...
- ...labeling professional to join our labeling strategy team. This team is responsible for... ...Philadelphia, PA Key Responsibilities Represent Global Labeling on product-specific Global... ...and Operations and Supply Chain to ensure submission-ready labeling components comply with...Local area
- AstraZeneca is seeking a Strategy and Commercial Executive Director, Cell Therapy Strategy and Commercial (CTSC), to shape end-to-end strategy for a defined... ...within the Cell Therapy Enterprise. You will lead global commercial and strategic initiatives, partner with Therapeutic...
- Takeda in Cambridge, MA is seeking a Director, Global Medical Lead for Zasocitinib in Psoriatic Arthritis (PsA) to drive the global medical strategy and align with clinical and enterprise priorities. The role provides medical leadership to cross-functional teams, shaping...Local area
$200k - $300k
A biopharmaceutical company in Cambridge is seeking a Director or Senior Director of Regulatory Strategy. This role involves developing and implementing global regulatory strategies for clinical programs and leading interactions with regulatory authorities. Candidates should...- AstraZeneca GmbH is seeking a Strategy and Commercial Executive Director for Cell Therapy Strategy and Commercial. You will shape end-to-end strategy across a defined indication, lead global commercial initiatives, and partner with Therapeutic Areas on clinical strategy...
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