Senior Director, Regulatory Strategy & Human Factors
BioSpace
Takeda in Boston, MA seeks a Senior Director and Regulatory Platform Lead focusing on GRA CMC, Human Factors for drug-device combinations. You will guide global regulatory strategies across device and pharmaceutical development, ensuring high-quality filings and right-first-time submissions. You will lead regulatory submissions with health authorities such as FDA and EMA, mentor teams on Human Factors, and drive lifecycle management while collaborating across a complex matrix to deliver #J-18808-Ljbffr BioSpace
$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... ...s position within the salary range will be based on several factors including, but not limited to, specific competencies,...SeniorPermanent employment- BioSpace is seeking a Senior Director of Regulatory Affairs in Boston. The role involves planning and executing regulatory strategies for gene-editing programs, managing submissions, and serving as a key contact with regulatory authorities. This position requires a Bachelor...Senior
- Servier is seeking a Senior Director, US Regional Regulatory Lead in Boston to drive regulatory strategy and influence team alignment in product development. The role demands exceptional leadership skills in navigating FDA interactions and regulatory affairs. Ideal candidates...SeniorRemote job
- Merck is seeking an Executive Director of Chemistry, Manufacturing, and Control for Biologics to manage CMC professionals and ensure compliance with global regulatory strategies. This senior role involves overseeing submissions for high-quality CMC for biologics products...Senior
- 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
- 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...Senior
- A biotech company is seeking a Senior Director of Regulatory Affairs for a fully remote role. This position involves leading regulatory strategy and compliance for early-stage drug development. The ideal candidate will have over 10 years of experience in regulatory affairs...SeniorRemote job
$210k - $235k
...clinical development, commercial strategy, and beyond. Innovation:... ...and geographies. The Director, Regulatory Strategy provides global regulatory... ...a key regulatory advisor to senior leadership and cross‑... ...may vary based on multiple factors including but not limited to...SeniorRemote workWorldwideFlexible hours$232k - $348k
Regulatory Strategy Senior Director The Senior Director of Regulatory Strategy leads the development and implementation of advanced global and regional... ...and/or complex projects in development (from first‑in‑human to post‑marketing application stage), as outlined in Global...SeniorLocal areaRemote workFlexible hours2 days per week3 days per week$187.5k - $275k
...editing medicines for serious diseases. Regulatory affairs collaborates cross... ...interested in building successful regulatory strategies. Verve is located in Boston, just down... ...from Fenway Park. Responsibilities The Senior Director, Regulatory Affairs is responsible for...SeniorFull timeWork at officeFlexible hours3 days per week$232k - $348k
Job Description The Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical... ...in development (from first-in-human to post-marketing application stage)... ...salary pay will be based on a number of factors, including skills, competencies,...SeniorSummer workLocal areaRemote workFlexible hours2 days per week3 days per week- Overview 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...Senior
- Scorpion Therapeutics is seeking a Regulatory Strategy Lead in Boston, MA. This role involves developing regulatory strategies focusing on Human Factors for devices and drug-device combinations. The ideal candidate will have over 10 years of regulatory CMC experience and...Senior
- Responsibilities Lead development and implementation of regulatory strategies for pure device and drug-device combination products with a focus on Human Factors across development, registration, commercialization, and lifecycle management. Maintain and communicate CMC/...SeniorNight shift
$212k - $333.19k
...patients worldwide. About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you will provide leadership for the... ...device and combination product regulatory strategies, particularly pertaining to the...SeniorFull timeTemporary workLocal areaWorldwideNight shift- ...global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named... ...ScholarRock and on LinkedIn. Summary of Position The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global Head of Regulatory...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... .... Act as a trusted advisor to senior leadership on promotional risk and... ...be determined based on various factors including, but not limited to, years...SeniorTemporary workLocal areaRemote workWork from homeFlexible hours3 days per week- Superluminal Medicines, Inc. is seeking an experienced Director/Senior Director of Human Resources to shape our HR strategy. You will be pivotal in aligning HR practices with the company’s growth ambitions while ensuring compliance with employment laws across diverse states...Senior
- ...Pharmaceuticals is seeking an Executive Director in Biostatistics, a senior leader responsible for developing statistical strategies for clinical programs. This hybrid position... ...of statisticians while interacting with regulatory authorities. The ideal candidate will hold...Senior
- ...Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and... ...objectives established by senior management. Advances the organization... ...range will depend on many factors including geographic...Worldwide
$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... ...candidate will depend on a variety of factors including the candidate's experience,...Temporary workLocal areaRemote workWeekend work- 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 affairs and a strong background in drug development. The ideal candidate will have over 12 years in the pharmaceutical...Senior
- Vertex Pharmaceuticals is seeking a Regulatory Strategy Senior Director to lead regulatory approaches for various projects. The role, located in Boston, is hybrid, requiring 3 days per week onsite. The ideal candidate will possess significant expertise in regulatory affairs...Senior3 days per week
- ...technology, and talent to get ahead of disease together. Position Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities, working with cross‑functional teams across development, manufacturing, quality and...SeniorWork at officeLocal areaRemote workWorldwide
$232k - $348k
Job Description The Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical... ...in development (from first-in-human to post marketing application stage)... ...salary pay will be based on a number of factors, including skills, competencies,...SeniorLocal areaRemote workFlexible hours2 days per week3 days per week$177k - $278.08k
...changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and... ...strategy and labeling content. Interface with Senior Management Cross‑Functional Team (GLOC) In alignment...Full timeTemporary workLocal areaWorldwide- A global biopharmaceutical company is seeking a Director of Regulatory Affairs to lead the Global Regulatory Strategy. This role involves developing strategies for securing market approval, ensuring compliance with regulatory requirements, and mentoring team members. Candidates...
- A global pharmaceutical company is seeking a Director of Regulatory Affairs to lead the development and implementation of global regulatory strategies for products in Boston. The ideal candidate will have over 5 years of regulatory experience, specifically in a strategic...
- CVS Health is seeking a seasoned professional to join the Network Strategy and Provider Experience team, ensuring compliance and regulatory readiness. The role will involve leading engagements across compliance and regulatory affairs, analyzing requirements, and managing...Work at office
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