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
$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
$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- ...in Boston, MA is seeking a Director Regulatory Site CMC to lead site-specific... ...management and regulatory submissions across small molecule and... ...years in biopharma with deep global HA regulatory experience,... ...to communicate regulatory strategy to cross-functional teams....Suggested
$177k - $278.08k
...patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for... ...functions.Labeling Documents Authoring, Submission, and Labeling Negotiations... ...including clinical, safety, medical affairs, and commercial, to ensure unparalleled...SuggestedMinimum wageLocal areaRemote workWorldwide$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- Hemab Therapeutics in Cambridge, MA is seeking a Director, Regulatory Affairs to shape and deliver global regulatory strategy for our rare bleeding disorder programs. You will sit close to science and development teams, turning complex data into clear regulatory choices...Remote work
- Discover International is seeking a Director, Global Regulatory Affairs — Oncology to lead regulatory strategy and execution for oncology programs. You will partner... ...clinical development teams to navigate milestones, submissions, and lifecycle activities. The ideal...
- ...Director-level regulatory affairs position leading global strategy development and market approval efforts for neuroscience products. Responsible for managing cross-functional teams, regulatory dossiers, and lifecycle management while ensuring compliance with global regulations...
- ...Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy (Neuroscience), is responsible for developing and implementing global strategies to secure...Local areaWorldwide
$196.7k - $353.4k
...Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory... ...unprecedented new drug modality globally. The Sr. Director will be... ...for regulatory submissions and related supplements and... ...overall plans to Regulatory Affairs the Project Team and senior...Permanent employmentFull timeWork at officeWork from home- We are expanding our regulatory capacity to keep pace... ...to the VP, Regulatory Affairs, the Global Regulatory Lead will... ...ownership of regulatory strategy and execution for an... ...at the Associate Director level (or 1-2 years at... ...leading global regulatory submission strategy and filing (...Flexible hours
- Takeda in Boston, MA seeks a Director of Regulatory Strategy to define and lead global regulatory strategies for complex programs, collaborating cross-functionally to ensure compliance and timely submissions. The role leads GRTs, coordinates health authority interactions...
$186.23k - $279.35k
...AstraZeneca seeks a Global Regulatory Affairs Director to provide strategic regulatory leadership for product development, commercialization, and... ...management Identify future regulatory requirements and strategies based on current local and global trends Engage with...Local area$187k - $253k
The Director of Technical Operations and Quality (TOQ) Strategic Sourcing has responsibility... ...ecosystems and developing sourcing strategies that support programs from early development... ...Resources, and other peers within the Global Strategic Sourcing organization.Qualifications...Full timeContract workTemporary workLocal areaFlexible hours- Pulpdent Corporation in Watertown, MA, seeks a Head of Regulatory Affairs to guide global regulatory strategy across R&D, manufacturing, and marketing. Lead a high-performing team, manage FDA submissions, and ensure compliance with EU MDR and ISO 13485. This on-site role...Worldwide
$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- ...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
...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 wageLocal 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
...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 wageLocal 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 wageWork at officeLocal areaRemote work$116.48k - $146k
...a critical enabler of that innovation. We’re seeking a Senior Global Supply Manager to lead strategic sourcing initiatives, strengthen... ...days / WFH 1 dayWhat You’ll DoOwn and execute global commodity strategies for complex, high-impact categories across multiple robotics...Full timeContract workWork at officeWork from home- ...Anika Therapeutics, Inc. seeks a Regulatory Affairs Project Manager/Sr. Manager... ...planning, execution, submission readiness, and program coordination across global teams. The role requires NDA... ...aligning with global regulatory strategies and business goals. #J-1880...
$154.4k - $242.55k
...? Join us as an Associate Director, Global Regulatory Project Management and Strategic... ...our Global Regulatory Affairs organization, based... ...cross‑functional project submission working groups (SWG) to deliver... ...accordance with regulatory strategy for complex programs. Partner...Minimum wageFull timeLocal areaRemote workWorldwide- Biogen is seeking a Head of Global Product Quality for Biologics to lead a dynamic PDQ team, ensuring quality across the biologics... ...processes. The role requires extensive QA leadership, regulatory submission oversight, and cross-functional collaboration with CMC teams...
$218.06k - $327.09k
...Are you ready to set the global regulatory vision for pioneering... ...labeling. You will shape strategy for complex, visible... ...report to the Executive Director, Cell Therapy Regulatory Affairs and act as a franchise... ...current stage through BLA submission, ensuring an efficient...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$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$137k - $215.27k
About the role: Lead the development and advancement of Global Patient Access strategies across programs. Ensure strategies align with enterprise priorities, regulatory requirements, and product lifecycle needs, and support timely, compliant patient access globally. This...Minimum wageFull timeContract workLocal areaRemote workNight shift- ...critical unmet need. As a global leader in myostatin... ...Position: The Associate Director, Regulatory Strategy, is responsible for the development... ...will represent regulatory affairs at the appropriate program... ...the preparation and submission of regulatory submissions...Shift work
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