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
- 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...Suggested
- ...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$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...SuggestedPermanent employmentFull timeWork at officeWork from home- ...professional to join our labeling strategy team. This team is... ...Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional... ...Supply Chain to ensure submission-ready labeling... ...in fields of Regulatory Affairs, Pharmacovigilance, and...SuggestedLocal area
- Arbor Biotechnologies is seeking a Director of Regulatory Affairs to lead regulatory strategy across its portfolio, spanning... ...programs. You will serve as the global regulatory lead and primary... ...and other authorities, guiding submissions, agency meetings, and data narratives...
- ...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
- 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...
- ...Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within... ...in the US and other global markets. Responsibilities... ..., including for IND submissions. Lead the strategy for US... ...May serve as regulatory affairs representative to provide...
- ...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- 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....
- ...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
- ...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-...
- 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
- Stoke Therapeutics seeks a Director of Global Regulatory Strategy to lead global regulatory planning, ensuring products move through development, approval, and maintenance in line with health authority expectations. The role reports to the Executive Director and requires...
- Collegium Pharmaceutical is seeking a Manager, Regulatory Affairs to provide regulatory support for marketed products and development programs... ...Responsibilities include preparing INDs and NDAs, managing submissions to FDA and other health authorities, maintaining #J-18808-...
$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$232.5k - $335.83k
...Job title: Head of Strategy and Management Office, Global Clinical DevelopmentLocation: Swiftwater, PA, Waltham, MAAbout the Job As Head of Strategy... ...office, including risk mitigation strategies, internal and regulatory audit readiness, training and onboarding programs,...Full timeWork at office$142.5k - $256.5k
The Role The Associate Director, Global Regulatory Advertising and Promotion will... ...between Regulatory Affairs, Legal, Medical, and Commercial... ...requirements. Guide promotional strategy as the Regulatory Ad Promo... .... Prepare regulatory submissions for promotional materials,...Permanent employmentWork at office- 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...
$142.5k - $256.5k
The Role The Associate Director, Global Regulatory Advertising and Promotion will... ...between Regulatory Affairs, Legal, Medical, and Commercial... ...requirements. Guide promotional strategy as the Regulatory Ad Promo... .... Prepare regulatory submissions for promotional materials,...Work at officeWork from home- ...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...
$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$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
...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...
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