Senior Director, Regulatory Affairs
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Flagship Pioneering seeks a Regulatory Counsel to join its Legal team. The role leads regulatory efforts tied to government contracting obligations and advises on GxP, consumer/digital health, and medical device matters across the company portfolio. Ideal candidates have a JD, active US bar, and 6–10 years of regulatory law experience, including global regulatory strategy and prior in-house or law-firm work. This is an in-person Cambridge, MA position with high visibility and impact. #J-18808-Ljbffr
$195k - $330k
...make an impact:Act as the global regulatory strategy lead for Kymera’s IRF5 degrader... ...to program teams and senior leadership.Manage and support junior... ...degree preferred but not required.Director: 8-10 years of Regulatory Affairs experience. Senior Director: 10-12...SeniorFlexible hours$275k - $315k
Position OverviewBicara 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...SeniorFull timeTemporary workWork at officeLocal area3 days per week- ...EMD Serono, Inc. is seeking a Senior Director to lead a team in regulatory review of promotional materials for U.S. prescription drugs. This role ensures compliance with FDA regulations and shapes the regulatory strategy across multiple therapeutic areas. The ideal candidate...Senior
$200k - $220k
...Director/ Senior Director, Regulatory CMC Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first‑and potentially best‑in‑class dual BAFF/APRIL...SeniorContract workWorldwideFlexible hours$220k - $290k
...innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to... ...the Corporation’s short and long‑term plans. The Senior Director, Regulatory Affairs has foresight, is action oriented, a problem‑solver, is...SeniorTemporary workFor contractorsWork at officeWeekday work$196.7k - $353.4k
...The Role: Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters... ...Sr. Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory plans...SeniorPermanent employmentWork at officeWork from home$196.7k - $353.4k
...The Role Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters... ...Sr. Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory plans...SeniorPermanent employmentWork at officeLocal areaWork from home$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to set the global regulatory vision for pioneering cell therapies and turn breakthrough...SeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week- Senior Manager - Regulatory Affairs Operations Location - Cambridge, MA (Hybrid) Oncology Biotech | Global Clinical Programs I’m currently supporting... ...regulatory submissions. The Role Reporting into the Director of Regulatory Affairs Operations, you will provide hands...Senior
- ...ID31521196Reference25-04484 The Global Regulatory Affairs (GRA) is responsible for obtaining approval... ...Reg Nonclinical / Clinical Associate Director will lead, conceive, communicate and... ...collaborate, influence and negotiate with senior Nonclinical / Clinical leaders on...Senior
- Job-ID32387836Reference26-00886 Job Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: This role is within...Senior
$220k - $370k
...Job Description Job Description Our Clinical Development team is seeking a highly motivated and experienced Senior Director or VP of Regulatory Affairs. The ideal candidate will have a proven track record of leading successful BLA submissions and desires to be part...SeniorSummer workWork at officeFlexible hours$259k - $317k
...and empowered to make an impact — both within our company and in the lives of patients we serve.Position Summary:The Senior Director of Regulatory Affairs is a senior leader responsible for developing and executing global regulatory strategy across the product portfolio....SeniorFull timeWork at officeFlexible hours- ...years professional experience in legal, regulatory, compliance environments; attorneys with... ...actionBuilds trust-based relationships with senior leaders within and outside of the team;... ...managing concerns.Your role reports to the Director of Ethics in Allegations Management.SeniorApprenticeshipWork at office
$195k - $330k
...the development and execution of global regulatory CMC strategies for degrader programs across... ...strategic regulatory CMC guidance to senior leadership regarding health authority interactions... ...readiness.Scale and lead the Regulatory Affairs CMC function as the pipeline and...Senior$196.7k - $353.4k
The RoleModerna 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 and...SeniorPermanent employmentFull timeWork at officeWork from home$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for... ...senior management on status of global Regulatory Affairs strategies and tactics, procedures and practicesLeads the...SeniorFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week- ...$170kJob Description An established organization is seeking a Senior Compliance Manager to support and drive compliance initiatives... ...processes, systems, and operations align with industry standards and regulatory requirements. This hands on position partners with cross...SeniorFlexible hours
$245k - $300k
...Job Description Job Description Description: Sr. Director, Regulatory Affairs At Merida Biosciences, we are pioneering true precision... ...Merida Biosciences is seeking an experienced and strategic Senior Director, Regulatory Affairs to lead and execute global regulatory...SeniorLocal area- Senior Regulatory Affairs Manager- REMOTE I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global phase 3 clinical trials of a certain product and support other clinical studies. This role includes driving global submission...SeniorFull timeRemote work
$157k - $173k
...For more information, please visit avalynpharma.com and follow the company on LinkedIn. Position Summary: The Senior Manager, Regulatory Affairs will support the development and execution of the global regulatory strategy and execution for Avalyn's development-stage...SeniorLocal area$172k - $280.5k
...SUMMARYThis is an outstanding career opportunity for a highly motivated Regulatory Counsel to join the Legal team at Flagship Pioneering. The... ...expectations for in-person attendance will be coordinated with senior management and may be adjusted from time to time based on...SeniorLocal area$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... ...such as understanding broad concepts within regulatory affairs and implications across the organization and globally;...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide- ...-accepted standards like GxP, ISO 9001, and 21 CFR Part 11. As Senior Compliance Manager, US, you will operate as an independent senior... ...for ensuring TetraScience's products and platform meet the regulatory expectations of the world's largest pharma and biotech customers...SeniorImmediate startFlexible hours
- ...Senior Director, IT Compliance & Governance (Contractor) About the Company Innovative company designing & developing gene therapeutic products Industry Biotechnology Type Public Company Founded 2013 Employees 51-200 Categories Biotechnology...SeniorFor contractors
- ...Staffing is assisting in the search for a Compliance Director - Private Equity (Credit Investment Funds)... ...advising on co-investments, affiliated transactions, and regulatory considerations while reporting to senior leadership and the board. #J-18808-Ljbffr Origin StaffingSenior
$180k - $240k
...leveraging autonomy today to solve some of aviation’s biggest challenges.About You: Merlin is seeking an experienced and detail-oriented Senior Manager of SEC Reporting & Internal Controls to join its growing Finance team. This role is critical to the company's public...SeniorFull timeContract work$251.77k - $307.72k
...More:We are seeking an experienced QMS and Digital Compliance Senior Director to lead transformational change within our quality... ...comprehensive global QMS governance framework ensuring compliance with regulatory requirements, industry standards, and company...SeniorFull time$155k - $195k
...ScholarRock on X and on LinkedIn.Summary of Position:The Senior Manager, Veeva Regulatory & Data serves as the technology lead for enterprise applications... ...readiness, and global growth.Reporting to the Senior Director, Commercial & Data, the Senior Manager partners closely...SeniorFull time- Rhythm Pharmaceuticals, Inc. is seeking an experienced Regulatory CMC professional to execute high-quality, compliant CMC deliverables... ...individual contributor role collaborates with Global Regulatory Affairs, Technical Operations, and Quality to ensure timely, complete...Senior
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