Senior Director, Regulatory Platform - Human Factors
Scorpion Therapeutics
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 strong communication skills. Responsibilities include influencing regulatory guidance, collaborating across teams, and ensuring compliance with global standards. Join us to shape future regulatory landscapes and make an impact! #J-18808-Ljbffr Scorpion Therapeutics
- 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/...PlatformSeniorNight shift
$212k - $333.19k
...in order to bring life‑changing therapies to 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 development and implementation of innovative...PlatformSeniorMinimum wageFull timeTemporary workLocal areaRemote workWorldwideNight shift$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy Introduction... ...working gives us the platform we need to connect, work at... ...on multiple individualized factors, including market location,... ...around what makes us human, we put a big focus on people...PlatformSeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week- ...accepted standards like GxP, ISO 9001, and 21 CFR Part 11. As Senior Compliance Manager, US, you will operate as an independent... ...IC — accountable for ensuring TetraScience's products and platform meet the regulatory expectations of the world’s largest pharma and biotech...PlatformSeniorImmediate startFlexible hours
$130k - $190k
Manager/Senior Manager Regulatory Affairs - Advertising, Labeling, and Promotion Cambridge, MA Added... ...establishing the leading, fully integrated platform for precision genetic medicines. To... ...portfolio. This role reports to the Director of Regulatory Labeling and serves as...PlatformSenior- ...broad application of a proprietary platform, which has developed novel monoclonal... ...to modulate protein growth factors with extraordinary selectivity. Scholar... ...Summary of Position: The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global...PlatformSeniorWork at officeLocal areaShift work
- ...Initial Therapeutics, 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...Senior
$89k - $180k
...: The Role As a Product Lead within the Regulatory Reporting Product team, you will be responsible... ...Bring Solid understanding of systems / platform dependencies, problem solving and... ...candidate’s relevant experience, and other factors. Base salary is only part of the total...PlatformSeniorFull timeWork from home- ...Position Overview Bicara 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 VP, Regulatory Affairs, you will serve as the primary US regulatory...SeniorWork at officeLocal area3 days per week
$270k - $330k
...Position Overview The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic leadership to assigned program(s) and implementing regulatory tactics to support the execution of regulatory activities across assigned region(...SeniorTemporary workWorldwideFlexible hours$270k - $330k
...The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic leadership to assigned program(s) and implementing... ...outcomes.Identify opportunities and limiting factors for optimal label and propose alternative solutions.Incorporate...SeniorTemporary workLocal areaWorldwideFlexible hours- ...Senior Executive Director, Regulatory Affairs About the Company Well-funded clinical-stage biotech company Industry Biotechnology Type Privately Held About the Role The Company is seeking a Senior Executive Director for Regulatory Affairs to play a pivotal role in the...Senior
- 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
$212k - $333.19k
...a lasting impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...Summary We understand compensation is an important factor as you consider the next step in your career. We are...SeniorMinimum wageTemporary workLocal areaWorldwide$250k - $330k
...Summary We are seeking an experienced and strategic Senior Director of Regulatory Affairs Advertising/Promotion to lead FDA-focused promotional... ...0 - $330,000. Final compensation will be determined based on multiple factors and may fall outside of the posted range....SeniorWork at office- A leading BioPharmaceutical company seeks a Senior Director, Global Regulatory Strategy, to lead regulatory efforts for early-stage products and ensure alignment with health authority expectations. The role demands extensive regulatory experience in the pharmaceutical...Senior
- ...therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing... ...'s short and long-term plans. The Senior Director, Regulatory Affairs has foresight, is... ...base salary will be based on several factors, including job-related skills, experience...SeniorTemporary workFor contractorsWork at officeWeekday work
$246.33k - $304.29k
Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney disease. This role demands extensive regulatory experience, with leadership responsibilities...SeniorFlexible hours$211.85k - $317.78k
...Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business Development Location: Boston, MA At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately...SeniorHourly payTemporary workWork at office3 days per week$133k - $170k
...other software/technology platforms. Tracking, reporting, and... ...operational activities align with regulatory requirements and the company’... ...determined based on several factors, including your experience,... ...National Commercial Business Director, Kineret Sobi Culture At...PlatformSeniorTemporary workSummer work- 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
$211.85k - $317.78k
...of rare disease research and make a meaningful difference in patients' lives. This is what you will do: The Senior Regulatory Affairs Director (Sr RAD), Global Regulatory Strategy, leads the development and implementation of global regulatory strategy for complex...SeniorHourly payTemporary workWork at officeFlexible hours3 days per week$116.71k - $175.06k
...partner closely with cross-functional colleagues in medical, legal, regulatory, commercial, and regulatory operations to drive high-quality... ...life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions....PlatformSeniorTemporary workWork at officeFlexible hours3 days per week$95k - $110k
Blackkite in Boston seeks a Senior GRC Analyst to manage compliance platforms and customer security assessments. The ideal candidate will have 2-4 years in GRC or information security, paired with skills in SOC 2 and ISO 27001. You'll support FedRAMP ConMon reporting and...PlatformSenior$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with cross-functional teams to ensure the success of innovative oncology therapies. The successful candidate...Senior- Moderna is seeking a seasoned scientific leader for a senior role in Nonclinical Safety Evaluation in Cambridge, MA. This role involves... ...teams, and developing nonclinical safety strategies to support regulatory submissions across therapeutic areas. Required qualifications...Senior
$212k - $333.19k
...Senior Director, Global Regulatory Lead – Oncology At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and... ...Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are...SeniorMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$248k - $372k
...lead performance and reliability initiatives. You will report to a VP of Engineering and drive architectural changes to enhance the platform's scalability. This is a hands-on role requiring deep technical expertise in performance engineering and an understanding of AI...PlatformSenior$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$220k - $249.47k
...Job Description Job Description Director, Regulatory & Scientific Writing – Solid Biosciences... ...advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in... ...analysis utilizing a combination of factors including, but not limited to, relevant...PlatformContract workTemporary workFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, Regulatory Platform - Human Factors. Be the first to apply!
- finance compliance manager Boston, MA
- sr. manager regulatory compliance Boston, MA
- quality compliance manager Boston, MA
- corporate compliance manager Boston, MA
- senior regulatory manager Boston, MA
- regulatory affairs manager medical devices Boston, MA
- director global regulatory affairs Boston, MA
- associate director compliance Boston, MA
- compliance director Boston, MA
- regulatory project manager Boston, MA



