Senior Director, CMC Regulatory Strategy & Science
Celldex Therapeutics, Inc.
Celldex Therapeutics, Inc. is seeking a Senior Director, Regulatory Science and CMC Development Strategy to lead early-stage CMC regulatory strategy and provide regulatory science across the Celldex portfolio. This senior leader reports to the VP, Regulatory Affairs and partners with Manufacturing and Quality to align development-phase CMC and readiness. Responsibilities include shaping phase-appropriate CMC regulatory strategies, supporting IND through late-stage development, GMP compliance, #J-18808-Ljbffr Celldex Therapeutics, Inc.
$203.16k - $263.84k
Overview The Senior Director, Regulatory Science and CMC Development Strategy is a senior Regulatory Affairs leader responsible for early-stage CMC regulatory strategy and for providing broad regulatory science expertise across the Celldex portfolio. Reporting to the Vice...Senior$210k - $320k
...wide range of therapeutic editing strategies that Beam is using to advance a... ...committed to its people, cutting-edge science, and a vision of providing life-... ...diseases.Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing...SeniorFull timeShift work3 days per week1 day per week$195k - $330k
...years. For more information about our science, pipeline and people, please visit or... ...the development and execution of global regulatory CMC strategies for degrader programs across all... ...strategic regulatory CMC guidance to senior leadership regarding health authority...Senior$196.7k - $353.4k
...Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy... ...within Global Regulatory Science, responsible for developing... ...in partnership with RA CMC and verifies accuracy of clinical... ...the Project Team and senior management, as relevant.May...SeniorPermanent employmentFull timeWork at officeWork from home$195k - $330k
...information about our science, pipeline and people,... ...impact:Act as the global regulatory strategy lead for Kymera’s IRF5... ...with Clinical, CMC, Nonclinical, Quality,... ...to program teams and senior leadership.Manage and... ...preferred but not required.Director: 8-10 years of Regulatory...SeniorFlexible hours$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... ...communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best...SeniorPermanent employmentFull timeWork at officeWork from home$242k - $313.5k
...Senior Director, Regulatory Affairs CMC – Small Molecule About Beeline Medicines: Beeline Medicines is... ...team and backed by world-class life science investors, each day Beeline Medicines... ...and executing CMC regulatory strategies from early clinical development through...SeniorLocal area2 days per week$224.9k - $404.6k
...responsible for managing a team of CMC experts that prepare and... ...agency correspondence and regulatory applications. This position will... ...to oversee the product strategy for all the products in their... ...to have been recognized as a Science Magazine Top Biopharma Employer...Permanent employmentFull timeWork at officeWork from home$235k - $335k
...years. For more information about our science, pipeline and people, please visit... ...an impact:Kymera is seeking a Senior/Executive Director, AI Strategy & Applications to serve as the company... ...Research, Clinical Development, Regulatory/CMC, and G&A to turn scientific and...Senior$190.4k - $285.6k
Director, Regulatory Affairs CMCSkip to main content#Director, Regulatory Affairs CMC page is loaded## Director, Regulatory... ...global regulatory strategies across multiple investigational... ....* Serves as senior Regulatory CMC... ...Affairs, Pharmaceutical Sciences, Engineering, or...Summer workRemote workFlexible hours2 days per week$142.5k - $256.5k
...RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal... ...effective CMC regulatory strategies for international submissions (e.g.... ...proud to have been recognized as a Science Magazine Top Biopharma Employer, a...Permanent employmentFull timeWork at officeWork from home$230k - $260k
...an alternative application process. Director, Regulatory CMC .25 Charlestown-HQ, Charlestown, MA,... ...in the pursuit of uniting experts in science, technology, disease management, and... ...and executing global Regulatory CMC strategies for the AAV gene therapy portfolio that...Temporary workFlexible hours- Takeda is seeking a senior leader to provide strategic scientific... ...management for multiple global CMC development teams. The role... ...pharmaceutical product development, regulatory affairs, and cross-divisional... ...influencing governance and strategy across Takeda’s divisions and...Senior
$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for... ...technical expertise in regulatory affairs science including advanced knowledge of regulatory frameworks and...SeniorFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$200k - $265k
.... We deliver an innovative, science-based portfolio of premium flagship... ...OpportunityLeads the global regulatory strategy, submission planning, and... ...clinical, non-clinical, and CMC development documentation as... ...verbal format to regulatory senior leadership team and other...Full timeTemporary workWork experience placementWork at officeWorldwide$142.5k - $256.5k
...Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal... ...implementing effective CMC regulatory strategies for international submissions (e.g.... ...proud to have been recognized as a Science Magazine Top Biopharma Employer, a...Permanent employmentWork at officeLocal areaWork from home$268.2k - $402.2k
## Executive Director, Regulatory Strategy, Cell & Gene TherapyApplylocations: Boston, MA: Washington, DCtime... ..., representing regulatory on the senior cross-functional teams providing... ...tactical expertise in regulatory affairs science including knowledge of regulatory frameworks...Summer workLocal areaRemote workFlexible hours2 days per week$250k - $273k
...Grounded in rigorous science and bold innovation, the... ...most.We're seeking a Senior Director, Quality Compliance reporting... ...alignment with regulatory requirements and industry... ...quality compliance strategy aligned with global regulatory... ....Collaborate with CMC, Regulatory Affairs,...SeniorWork at office- Moderna is seeking a Principal Scientist in Norwood, MA to lead quantitative science across CMC. You will deliver advanced statistical solutions, guide regulatory submissions, and deploy data‑driven tools that inform decision making. The role requires strategic vision,...
$216.3k - $324.5k
...Job Description Senior Director, Regulatory Transformation & Innovation Job Summary The Senior... ...a transformation and innovation strategy that modernizes GRA-related processes... ...experience in Regulatory Affairs, life sciences, or other regulated industries, with...SeniorSummer workRemote workFlexible hours2 days per week3 days per week$258.83k - $293.48k
...Madrigal Pharmaceuticals seeks a Senior Director of Regulatory Affairs CMC to lead strategy and execution for chemical manufacturing and controls across clinical... ...to management Requirements BS in life sciences or healthcare field; advanced degree strongly preferred...Senior- ...Kymera Therapeutics seeks a Director or Senior Director of Regulatory CMC to lead global regulatory strategy for targeted protein degradation programs across development stages. The role encompasses CMC regulatory submissions, health authority interactions, and oversight...Senior
$206.25k - $343.75k
...Job Title Senior Director, Access Strategy Oncology Location Cambridge, MA or Morristown, NJ... ...Together, we chase the miracles of science to improve people’s lives. Main Responsibilities... ...and adapt to changes in the regulatory and reimbursement landscape,...Senior$210k - $320k
...range of therapeutic editing strategies that Beam is using to... ...its people, cutting-edge science, and a vision of providing... ...talented and motivated Sr. Director / Director of CMC, to lead our advancing portfolio... ....Work directly with regulatory and key stakeholders on the...SeniorFull time$190.8k - $300.3k
...Job Description Description The Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison reports to the Executive Director or Associate... ...development and implementation of worldwide regulatory strategies for their assigned projects in the General Medicine...SeniorFull timeFor contractorsLocal areaRemote workWorldwideRelocationVisa sponsorshipFlexible hoursShift work$190k - $200k
Senior Manager - Consumer Sector - Retail StrategyIn the United States - New York | Chicago... ...every lever of their commercial strategy - brand and value proposition, assortment... ...primary consumer research, and behavioral science. We are hiring a Senior Manager level individual...SeniorWork at officeWork from homeFlexible hours$236k - $324.5k
...company, one that maintains its roots as a science-based start-up and pushes our commitment... ...Commercialization Leadership Team by translating strategy into focus, decisions, execution, and scalable ways of working. The Senior Director will operate at the intersection of...SeniorFull timeTemporary workWork at officeLocal areaFlexible hours$250k - $280k
...recurrent pericarditis. Grounded in rigorous science and bold innovation, the company... ...seeking a strategic, enterprise-minded Senior Director, Healthcare Compliance reporting to VP,... ...area leadership, ensuring that business strategy aligns to laws, regulations, and Kiniksa...SeniorWork at office- ...with limited options through rigorous science and a collaborative, mission-driven... ...Primary Responsibilities The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing, and Controls... ...and executing regulatory strategies for CMC activities across the company...Remote workFlexible hours
- Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs, develop global submission plans, and coordinate cross-functional teams to ensure regulatory success...Senior
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