Senior Director, Global Regulatory Strategy
Socket.dev
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 Socket.dev
$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- Scorpion Therapeutics in Boston seeks a Senior Global Regulatory Leader to drive regulatory strategy across oncology programs from discovery through late-stage development. You will lead global regulatory teams, coordinate with GPT, and guide cross-functional priority...Senior
$167k - $300.7k
The Role Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within the... ...Director will be a strategic leader within Global Regulatory Science, responsible for... ...Team, Project Development Team and senior management, as relevant....SeniorPermanent employmentWork at officeWork from home- Moderna Therapeutics seeks a Sr. Director of Regulatory Strategy to support oncology programs from its Cambridge headquarters. This forward-looking regulatory strategist will develop and execute global plans, articulate compelling strategies, and navigate US/EU regulatory...Senior
- The Role: Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters... ..., will be relied on to articulate clear and compelling global regulatory strategies, highlighting risks and...SeniorWork 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$232k - $348k
Job DescriptionThe 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 advanced...SeniorFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$180k - $245k
...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs... ...for developing and executing regulatory strategies that support global product development and registration...$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... ...complex challenges and ideas into actionable strategies. You will set global regulatory direction, provide expert...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide- ..., LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for developing and implementing... ...the program objectives established by senior management. Advances the organizations goals...Temporary workWorldwide
- ...experienced labeling professional to join our labeling strategy team. This team is responsible for developing... ...or Philadelphia, PA Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development...Local area
- ...Therapeutics in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-functionally to... ...global requirements. You will influence senior stakeholders, oversee USPI/CCDS labeling...Work at officeRelocation
- ...Reference26-00886 Job Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices... ...CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global...Senior
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring... ...and compliance programs Implement compliance strategies and processes Prepare, review, and approve regulatory compliance...SeniorFull timeLocal area
- Vertex is seeking an Executive Director of Regulatory Strategy to lead global regulatory efforts for its Type 1 Diabetes portfolio. You will guide senior cross-functional teams, shaping strategy and liaising with health authorities while driving program leadership and...
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...keeping leadership appropriately informed and involving senior management at key decision points. Able to manage...Local areaFlexible hours2 days per week- ...company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires... ...particularly in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and...
- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one of... ...vaccines based on messenger RNA technology in the US and other global markets. Responsibilities Serve as the global...
$200k - $265k
...create an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for... ..., and risks in written and verbal format to regulatory senior leadership team and other governing bodiesExperience interfacing...Full timeTemporary workWork experience placementWork at officeWorldwide- ...Moderna Therapeutics in Cambridge seeks a Sr. Director of Regulatory Strategy to lead global regulatory plans for oncology programs, guiding filings and interactions with health authorities. This newly created role demands strategic vision, deep regulatory knowledge,...
$265k - $331k
...Summary Genetix is seeking an experienced and strategic Senior Director of Regulatory Strategy to lead regulatory strategy and health authority... ...Administration (FDA) and will play a critical role in shaping global regulatory strategy for approved products. The...SeniorFull timeWork at officeFlexible hours3 days per week- Agomab Therapeutics is seeking a Senior Director of Medical Writing to lead the regulatory writing function across multiple programs. This strategic role embeds... ..., and Pharmacovigilance to shape narrative strategy, improve document quality, and ensure submission readiness...Senior
- Arbor Biotechnologies is seeking a Director of Regulatory Affairs to lead regulatory strategy across its portfolio, spanning preclinical and early clinical programs. You will serve as the global regulatory lead and primary contact with FDA and other authorities, guiding...
- Treeline Biosciences in Watertown, MA is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities, shape strategy, and manage submissions across INDs, NDAs, and BLAs. The role requires 8+ years in regulatory affairs...
- Monte Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic role involves developing and executing regulatory strategies to support global product development, particularly in immunology. The successful candidate will have at...
- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead global regulatory plans for assigned programs in rare, autoimmune and oncology portfolios. You will shape strategy, communicate risks and opportunities, and negotiate with health authorities in the US and...
- ...United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... .... This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate...
- Vertex Inc. seeks a Director of Global Submission Management to strategically oversee a portfolio of regulatory submissions across development and lifecycle programs. The role partners with Regulatory Strategy, CMC, Labeling, and Publishing to ensure timely, compliant submissions...
- Stoke Therapeutics seeks a Director of Global Regulatory Strategy to lead global regulatory planning, ensuring products move through development, approval, and maintenance in line with health authority expectations. The role reports to the Executive Director and requires...
- 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-impact oncology programs. You will collaborate with cross-functional teams to...
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