Global Regulatory Affairs Director — Strategy & Submissions
Treeline
Treeline in the United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable laws and guidelines. This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes. Ideal candidates thrive in a small, dynamic environment with broad responsibilities and a track record of delivering successful regulatory outcomes in biotech or #J-18808-Ljbffr Treeline
- ...pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational... ...candidate will prepare regulatory submissions, interact with health authorities... ...role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema...Suggested
$196.7k - $353.4k
...Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology... ...leader within Regulatory Affairs, responsible for developing... ...articulate clear and compelling global regulatory strategies,... ...accountability for regulatory submissions and related supplements...SuggestedPermanent employmentFull timeWork at officeWork from home- Beam Therapeutics is seeking a Regulatory Director/Sr. Director Regulatory CMC to lead global regulatory CMC submissions and ensure compliant health authority communications.... ...partners with cross-functional teams to shape strategies for IND/CTA/MF and BLA/MAA filings. The...Suggested3 days per week1 day per week
- Repertoire Immune Medicines is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy for Phase 1/2 oncology programs, based in Watertown, MA with in-office presence at least 3 days a week. The role will own INDs/CTAs, health authority...SuggestedWork at office3 days per week
$186.23k - $279.35k
...strategic and operational regulatory leadership to the... ...of current local and global Regulatory trends to identifyfuture... ...requirements and strategies. Influence Regulatory... ...and local Regulatory Affairs interface enabling rapid andeffective submissions, approvals and other...SuggestedFull timeTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week- ...an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic... ...experience in regulatory affairs, particularly in oncology,... ...alignment between US and global strategies. Exceptional communication... ...and regulatory submissions. The role offers robust healthcare...
$200k - $265k
...an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for... ...agreed timelines. Accountable for the Global Regulatory Affairs team supporting nemolizumab and for driving successful...Full timeTemporary workWork experience placementWork at officeWorldwide$225k - $275k
Senior Director, Global Regulatory Strategy Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly... ...NDA planning, preparation, and submission efforts. The role requires extensive... ...sub-teams and represent Regulatory Affairs on cross-functional governance and...Full time- ...us at Follow @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...Worldwide
- Sarepta Therapeutics in Cambridge, MA, seeks a Director, Global Transparency & Compliance Operations to lead global transparency programs and governance. The role partners with Finance, vendors, and cross-functional stakeholders to ensure compliant reporting and data integrity...
$100 per hour
The Director of Technical Operations and Quality (TOQ... ...and developing sourcing strategies that support programs... ...peers within the Global Strategic Sourcing organization... ...Secretary of Veterans Affairs; or A person who was... ...pursuant to VEVRAA. Submission of this information is...Full timeContract workTemporary workFor contractorsFor subcontractorWork at officeLocal areaFlexible hours$266.25k - $384.58k
Job title: Global Head, Regulatory Science — Model-Enabled Development, Real... ...and cutting-edge regulatory strategies across therapeutic areas.... ...regulatory strategies and submissions.Develops and Implements... ...10-15 years of regulatory affairs experience with demonstrated...Full timeWorldwideShift work- Biogen in Cambridge, MA seeks a senior regulatory strategy leader to drive asset strategy and ensure GMP/GCP compliance across modalities. The role involves shaping regulatory submissions, coordinating cross-functional teams, and mentoring staff to enable agile growth....
$187k - $253k
...Overview:The Director of Technical Operations and Quality (TOQ) Strategic Sourcing has responsibility... ...ecosystems and developing sourcing strategies that support programs from early... ...Human Resources, and other peers within the Global Strategic Sourcing organization....Full timeContract workTemporary workLocal areaFlexible hours- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The... ...programs Implement compliance strategies and processes Prepare,... ...and managing regulatory submissions with minimal guidance Skilled... ...knowledge in regulatory affairs Strong strategic planner...Full timeLocal area
$178.5k
Posting Description MANAGING DIRECTOR, GLOBAL STRATEGIC ALLIANCES, Computer Science and Artificial Intelligence, will establish the goals, strategic vision, structure, business models and organization of the Alliances department for CSAIL; develop the department’s budget...Full timeVisa sponsorshipNight shift- Noema Pharma in Massachusetts is seeking a Director of Regulatory Affairs to lead regulatory strategy and execution across clinical programs, reporting to SVP Regulatory Affairs. You will drive IND/NDA submissions, interact with FDA, and build regulatory capabilities across...
- ...benefits, see our website: The Importance of the Role The Director, Global Transparency & Compliance Operations is a pivotal member of... ...program , including governance, operational execution, disclosure submissions, publications, compliance certifications, reporting...Work at office
- ...Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ..., registration and/or post-approval strategies for assigned products. RA CMC member... ...development of robust and accurate submissions. Develops constructive relationships...
$180k - $245k
...seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our... ...and executing regulatory strategies that support global product development... ....Lead the preparation, submission, and maintenance of regulatory...$177k - $278.08k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ...Independently develops the regulatory CMC strategy and leads the execution of regulatory... ...CMC aspects of global registrational submissions of complex drug product or suite of...Minimum wageTemporary workLocal areaRemote workWorldwide$177k - $278.08k
...therapies to patients worldwide.The Director Global Regulatory Affairs, Neuroscience is responsible for... ...developing innovative global regulatory strategies and providing strategic regulatory... .... Accountable for all US FDA submissions and approvals of project(s) of responsibility...Minimum wageTemporary workLocal areaRemote workWorldwide$212k - $333.19k
...shine? Join us as a Senior Director, Global Program Lead- Neuroscience... ...The GPL defines the asset strategy and leads all development and... ...to simultaneously driving regulatory approval as well as launch... ...through large-scale Phase III/submission projects and global launch...Minimum wageTemporary workWork at officeLocal areaRemote work- # Director, Portfolio Strategy - Global InitiativesFlagship PioneeringDirectorVenture CapitalHealthcare, Biotech & Life SciencesFull-timeLocationCambridge, United StatesDate PostedJune 5, 2026RegionNortheastStay ahead of the marketGet instant notifications when new job...
- InforCapital, partnership is seeking a Director of Portfolio Strategy - Global Initiatives in Cambridge, United States. This high-impact role involves shaping a BioMedicines R&D portfolio from early discovery through clinical development and commercialization. The ideal...
$175k - $225k
...critical unmet need. As a global leader in myostatin biology... ...of Position The Associate Director, Regulatory Strategy, is responsible for the... ...will represent regulatory affairs at the appropriate program... ...directing the preparation and submission of regulatory submissions...Shift work- Alnylam Pharmaceuticals seeks a Director, Global Compensation to lead compensation for the Global Commercial organization. You will guide base... ...to ensure market competitiveness and alignment with business strategy. You will perform market analyses, benchmarking, and modeling...
$238k - $374k
...to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination... ...innovative and robust regulatory strategies for medical devices and drug-device... ...regulatory strategy and major submissions for an assigned portfolio of medical...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert... ...strategy for the assigned global or regional position and... ...including for regulatory submission documents and Health Authority... ...of global Regulatory Affairs strategies and tactics, procedures...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston... ...to role: Are you ready to set the global regulatory vision for pioneering... ..., from current stage through BLA submission, ensuring an efficient route to approval...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week
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