Senior Director, Regulatory Strategy & Compliance
Jobtailor
Jobtailor in Boston seeks an experienced Regulatory Affairs leader to provide strategic regulatory advice for product promotion, disease state education, and Medical materials in alignment with FDA regulations. You will collaborate cross-functionally with Commercial, Medical Affairs, Legal, Compliance, and Development, monitor regulatory trends, and oversee submission of materials to FDA, ensuring accuracy and timeliness. #J-18808-Ljbffr Jobtailor
$196.7k - $353.4k
...The role Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development...SeniorPermanent employmentWork at officeWork from home- Vertex Pharmaceuticals Inc (US) is seeking a Regulatory Strategy Senior Director to lead the development of regulatory strategies for complex projects. This central role is based in Boston and involves overseeing regulatory submissions and communications. The successful...Senior
- Moderna is seeking a seasoned scientific leader for a senior role in Nonclinical Safety Evaluation in Cambridge, MA. This... ...Pathology, managing teams, and developing nonclinical safety strategies to support regulatory submissions across therapeutic areas. Required...Senior
$232k - $348k
Regulatory Strategy Senior Director The Senior Director of Regulatory Strategy leads the development and implementation of advanced global and regional regulatory strategies for development programs, registered Vertex medicines, and Vertex marketed products. This executive...SeniorLocal areaRemote workFlexible hours2 days per week3 days per week- We are seeking an experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory consulting organization. This is a high-impact leadership role focused on providing strategic regulatory guidance to biotechnology...Senior
- ...ScholarRock and on LinkedIn. Summary of Position The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global Head of Regulatory... ...regulatory strategies and drive proactive plans to ensure compliance Monitor and analyze global and country specific...SeniorWork at officeLocal areaShift work
$183.55k - $275.32k
Director/Sr. Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory Who we are: At Agios, we are... ...communications to ensure compliance with applicable regulations, including... ...readiness. Act as a trusted advisor to senior leadership on promotional risk...SeniorTemporary workLocal areaRemote workWork from homeFlexible hours3 days per week- A leading cancer research organization located in Brookline is seeking a Regulatory Compliance Director to develop and oversee a comprehensive compliance program. The ideal candidate will have significant experience in regulatory healthcare compliance and leadership. This...Senior
$150k - $300k
...seeking an accomplished and driven Senior Director of Strategy to drive the adoption and growth of... ...management, and overall operational compliance. Support Sales Teams - Partner deeply... ...research sites, sponsors, and CROs. Regulatory Knowledge: Familiarity with GCP, ICH...SeniorLocal areaFlexible hours- Hebrew SeniorLife seeks an Executive Director to lead a senior living community, accountable for financial performance, resident well-being, and regulatory compliance. The role drives strategy, people development, and high-quality care while coordinating with multiple stakeholders...SeniorLocal area
$212k - $333.19k
...Defines, develops and leads global strategies to maximize global regulatory success towards achievement of... ...maintenance of programs, while ensuring compliance with applicable regulatory... ...counterparts. Accountabilities The Senior Director will be responsible for complex...SeniorMinimum wageTemporary workLocal area$205k - $341.6k
...Director Regulatory Affairs The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products... ...in close collaboration with leads from other areas. Assure compliance with regulations and with project team timelines....Local areaRelocation package$182k
...( Job Description The Director Regulatory Affairs Global Regulatory Lead... ...GRL II), Global Regulatory Strategy, is responsible for... ...regulatory risks. Ensures compliance with global regulatory requirements... ...objectives established by senior management. Advances the...Local areaWorldwide- A leading biotechnology company in Boston is seeking a Regulatory Strategy Senior Director to oversee global regulatory strategies for development programs. The role involves leading regulatory strategy development, ensuring cohesive integration of regulatory ideas, and...Senior3 days per week
- Initial Therapeutics, Inc. is seeking a Senior Director to lead global regulatory strategies in Boston. This role requires extensive experience in regulatory... ...cross-functional collaboration to ensure project compliance. Attractive compensation and benefits provided, including...Senior
$232k - $348k
Job Description The Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of...SeniorLocal areaRemote workFlexible hours2 days per week3 days per week$177k - $278.08k
...patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for... ...labeling content. Interface with Senior Management Cross‑Functional Team (... ...up‑to‑date information and in compliance with labeling requirements. Works...Full timeTemporary workLocal areaWorldwide$196.8k - $295.2k
Job Summary The Regulatory Strategy Director will be responsible for the development and implementation of innovative global and regional regulatory strategies for assigned projects within Vertex portfolio. This position will play a major role in shaping cohesive regulatory...Local areaRemote workFlexible hours2 days per week- Join Takeda as the Director of Global Regulatory Labeling Strategy, based in Boston, MA. You will be responsible for developing and implementing labeling... ...strategic regulatory thinking, focused on ensuring compliance and alignment with business objectives. Takeda offers...
- ...medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities... ...managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...Senior
- ...Executive Director, Regulatory Affairs Strategy, Cell & Gene Therapy About the Company Respected biopharmaceutical company Industry Pharmaceuticals... ...About the Role The Company is seeking a Senior Director for Regulatory Affairs Strategy in Cell and Gene...Flexible hours
- JobRx, Inc. is looking for a Director to define and lead global regulatory strategies in Boston, MA. The ideal candidate will manage the Global Regulatory Teams, ensure compliance with regulatory requirements, and oversee all FDA submissions. The role demands strong leadership...
$185.6k - $278.4k
General Summary The Regulatory Labeling Director will lead the strategic development... ...Responsibilities Ensures compliance with labeling governance... ...global regulatory teams and senior labeling governance... ..., GB, CA). Leads labeling strategy with expert ability to advise...Remote jobFull timeLocal area2 days per week$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience... ...major submissions and ensuring regulatory compliance. This position offers a hybrid work model...- ...Senior Regulatory Affairs Manager- REMOTE I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through... .../health authorities Monitor regulatory timelines and ensure compliance with all applicable regulations for IND maintenance Lead in...SeniorFull timeRemote work
- ...Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful... ...candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants...Senior
- Travere Therapeutics is seeking a Senior Director, Program Management in Boston, MA, to lead its development program in rare immune-mediated kidney diseases. The ideal candidate will have extensive experience managing cross-functional teams and complex drug development...Senior
- ...Job Description Job Description The Director, Regulatory Strategy is a key leadership role responsible for developing, implementing, and managing... ...through complex regulatory environments, ensuring compliance with all applicable laws, standards, and industry best practices...Remote jobFull timeLocal area
- ...Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics pipeline. Reporting to the... ...of global regulatory plans. Ensure compliance with applicable global regulations and internal...SeniorWork at officeLocal area3 days per week
- EY is seeking a Senior Manager for its Life Sciences Regulatory Submissions practice based in Boston. This role focuses on driving growth and establishing EY as a leader in regulatory compliance. The ideal candidate will have extensive experience in regulatory submissions...Senior
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