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
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global Regulatory Affairs Director — Strategy & Submissions in Watertown, MA vacancy
- ...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
$167k - $300.7k
...The Role:Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within the... ...will be a strategic leader within Global Regulatory Science, responsible for... ...development content and management of submissions to Health Agencies.Sets strategic direction...SuggestedPermanent employmentFull timeWork at officeWork from home- Moderna, Inc. seeks a Director of Regulatory Strategy to lead global regulatory programs across rare, autoimmune and oncology portfolios, shaping plans... ...teams, negotiate with health authorities, and drive submissions while monitoring developments in mRNA regulation. This...Suggested
- GlaxoSmithKline in the United States seeks a Senior Director, Global Regulatory Strategy - Oncology to lead regulatory strategies for asset development... ..., Clinical, Safety, and Commercial teams to shape submissions and ensure regulatory alignment across regions. The position...Suggested
- ...Job Title: Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy Responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory...Suggested
AbbVie
Cambridge, MA3 days ago $272.57k - $327.09k
...and reach more patients globally. Working here means being... ...development at every step. Senior Director, Global Regulatory Strategy will be responsible for... ...applications, paediatric submissions, etc.). Leads across... ..., Commercial, Medical Affairs, amongst others) to...Temporary workWork at office3 days per week- 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....
$167k - $300.7k
...seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will... ...through commercialization Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and urgency Lead...Permanent employmentFull timeWork at officeWork from home$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$260k - $290k
...treatments Job Description The Head of Global Regulatory Advertising & Promotion will report to... ...communications of assigned brand(s), submission to FDA OPDP/APLB, and be the owner of... ...Sobi policies. Provides vision, strategy and leads the adpromo team reporting...Temporary workWork experience placementSummer workWork at officeSobi
Waltham, MA15 days ago$178.1k - $244.86k
...with local requirements.OBJECTIVES/PURPOSELead development and advancement of Global Patient Access (GPA) strategies across programs, ensuring alignment with enterprise priorities, regulatory requirements, and product lifecycle needsDrive data-driven and technology-enabled...Minimum wageTemporary workLocal areaNight 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$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- ...Scholar Rock is a late-stage global biopharmaceutical... ...Summary of Position: The Director or Senior Director, Regulatory Strategy, reporting to the SVP,... ...Global Head of Regulatory Affairs, is responsible for the... ...the preparation and submission of regulatory submissions...Work at officeLocal areaShift work
$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$238k - $374k
...the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-... ...deliver innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase...Minimum wageTemporary workLocal areaRemote work$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$240k - $320k
...OpportunityThis role leads US regulatory policy and advocacy... ...change.Working across global and US-based teams,... ...science-driven policy strategies, engages with... ...staff, US government affairs staff, R&D functions,... ...engagement, regulatory submissions, and Health Authority...Full timeTemporary workWork experience placementWork at officeWorldwide$248k - $280k
...information, visit Position Purpose The Director, Global Regulatory Strategy will be responsible for developing... ...strategy. Oversee preparation and submission of global regulatory submissions to... ...8+ years minimum of Regulatory Affairs experience in the pharmaceutical industry...Temporary workStoke Therapeutics
Bedford, MA4 days ago$186.23k - $279.35k
...about science and experienced within regulatory affairs and drug development? Do you... ...regulatory affairs to get involved in the global regulatory strategies and support the research,... ...the business. The Regulatory Affairs Director (RAD) provides strategic and operational...Hourly payFull timeTemporary workWorldwide3 days per week$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory... ...developing global regulatory CMC strategies and collaborating with key stakeholders... ...regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify...Permanent employmentFull timeWork at officeWork from home$268.2k - $402.2k
...DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned... ...of innovative global regulatory strategies for... ...and quality of regulatory submission documents and Health Authority... ...of global Regulatory Affairs strategies and tactics, procedures...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg,... ...to role: Are you ready to set the global regulatory direction for first-in-class... ...product labeling, and accelerate submissions across multiple indications and...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$212k - $318k
...patients faster than ever before.The Director, T1D will serve as a T1D Market... ...Gene Therapy (CGT) portfolio in the Global Value and Access Strategy (GVAS) team.The individual will be responsible... ...HEOR, International P&R, Corporate Affairs, US Managed Markets, Countries,...Full timeSummer workRemote workFlexible hours2 days per week$189k - $246k
Department: 107000 Regulatory Location: San Diego, USA- Remote Position Summary The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase... ...requirements. Regulatory Submissions Oversee the preparation...Temporary workLocal areaRemote workWeekend work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Affairs Director — Strategy & Submissions. Be the first to apply!
Related searches
- regulatory cmc Watertown, MA
- regulatory Watertown, MA
- clinical research regulatory Watertown, MA
- pharmaceutical regulatory affairs Watertown, MA
- vendor compliance Watertown, MA
- medical compliance Watertown, MA
- regulatory compliance Watertown, MA
- compliance technician Watertown, MA
- compliance lead Watertown, MA
- compliance team leader Watertown, MA