Associate Director, CNS Regulatory Strategy
Seaport Therapeutics
Seaport Therapeutics is seeking an Associate Director, Regulatory Affairs in Boston to lead regulatory project teams across early and late development programs for CNS therapies. You will oversee global planning, interact with FDA/EMA/PMDA, and ensure integration of regulatory requirements from preclinical through Phase III readiness.
The role emphasizes hands-on leadership, cross-functional collaboration, and a strong track record in IND/CTA and NDA/MAA submissions, with onsite work four days
#J-18808-Ljbffr- Ipsen Biopharmaceuticals Inc. seeks an Associate Director, Global Regulatory Affairs to lead regulatory strategies for development and marketed products across regions. The role interfaces with R&D, Franchise, and Commercial Ops, ensuring compliant, efficient execution...Suggested
$175k - $225k
...neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn. Summary of Position: The Associate Director, Regulatory Strategy, is responsible for the development and implementation of regulatory strategy and plan for assigned clinical and/or...SuggestedShift work$154.4k - $242.55k
Job Description Objective / Purpose The Associate Director, Regulatory Business Systems & Capability Strategy supports the definition and execution of regulatory capability strategy within GRIDS. This role partners with Business System Owners and Business Process Owners...SuggestedMinimum wageFull timeLocal areaWorldwide- ...Anagram Therapeutics, Inc. in Natick, MA is seeking an experienced Associate Director to lead Regulatory Affairs CMC across development and lifecycle stages. You will plan submission strategies, prepare CMC documents for INDs/NDAs/BLAs, and collaborate with cross-functional...Suggested
- ...Rapport Therapeutics seeks an Associate Director of Regulatory Strategy to develop and execute regulatory pathways for a small-molecule neuromedicine pipeline. This Boston-based role involves cross-functional collaboration, regulatory authority engagement, and strategic...Suggested
$143k - $233k
As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs. Your Role: With minimal supervision, accountable for developing and leading...$154.4k - $242.55k
...a lasting impact on patients worldwide.Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the global regulatory... ...Oncology, you will define and lead global regulatory strategies for oncology programs, oversee major submissions, and...Minimum wageLocal areaRemote workWorldwide- ...Takeda Pharmaceutical Co. is seeking an Associate Director to drive regulatory business systems and capability strategy from Boston, MA. You will translate regulatory needs into scalable system capabilities, align stakeholders, and enable structured requirements for efficient...
- ...Taylor Strategy Partners is seeking an Associate Director, Medical Writing to lead regulatory and clinical documentation. The role reports to the VP of Regulatory Affairs and supports submissions across the US, UK, and EU, coordinating with vendors and cross-functional...
$142.5k - $256.5k
...The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements... ...applicable regulatory requirements. Guide promotional strategy as the Regulatory Ad Promo representative during early...Permanent employmentWork at office$142.5k - $256.5k
...radically changing the biotech industry.Reporting to the Director, Regulatory Information Management (RIM), the Associate Director, Regulatory Data Management &... ...defining and advancing Moderna’s regulatory data strategy, governance framework, and digital data ecosystem...Permanent employmentFull timeFor contractorsWork at officeWork from home$150k - $214k
The Opportunity Reporting to the Executive Director, Head of Regulatory Project Management, you will support the planning, coordination, and execution... ...leaders and cross-functional teams, ensuring regulatory strategies are translated into integrated, actionable plans that...Work at office$170.9k - $231.3k
OverviewThe Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data...Full timeTemporary workLocal areaWorldwideFlexible hours2 days per week$190k - $240k
...Location Remote Reporting to Executive Director, Regulatory Science Orchard Therapeutics, a Kyowa Kirin company, is a global gene... ...which is responsible for the development of global regulatory strategy and execution of regulatory activities for ex-vivo Gene...Odd jobLocal areaRemote work$170.9k - $231.3k
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic...Full timeTemporary workWork at officeLocal areaFlexible hours$154.4k - $242.55k
...therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and... ...regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory...Minimum wageLocal areaRemote workWorldwide$154.4k - $242.55k
...and tactical guidance to teams for the delivery of global regulatory strategies to support development and commercialization of biomarkers,... ...drafting and reviewing guidance comments and supporting trade association working groups.Education & Competencies (Technical and...Minimum wageLocal areaRemote work$160.8k - $201k
...benefits, see our website: The Importance of the Role The Associate Director, Regulatory Labeling and Disclosures, will be responsible for leading... ...Contributes to the formulation of global labeling strategy and assists international regulatory colleagues in development...Work at officeLocal areaImmediate startWorldwide$182k - $211k
...actions. ESSENTIAL JOB FUNCTIONS: The Director, Medical Writing, serves as... ...also provide guidance on document strategy for more complex dossiers for regulatory submission such as IND and NDA/BLA... ...or Veeva. The base range for an Associate Director is $182,000 - $211,000 and...Contract workSummer holidayWork at officeHome office- ...Fair360 and others. If you're as passionate about your future as we are, join our team.KPMG is currently seeking an Associate Director, Corporate Strategy to join our Corporate Strategy organization.Responsibilities:Support first-principles thinking to define firm-level...H1bLocal areaShift work
$154.4k - $242.55k
...information I submit in my employment application is true to the best of my knowledge.Job DescriptionJoin Takeda as Associate Director, Consumer Omnichannel Strategy, Psoriatic Arthritis of our Cambridge, MA office. The Associate Director, Consumer Omnichannel Strategy,...Minimum wageWork at officeLocal areaRemote work$196.7k - $353.4k
The Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters or one of Moderna’s East Coast hubs. This role is intended for a forward looking, creative regulatory strategist able to...Permanent employmentFull timeWork 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. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address...Permanent 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... ...industry/agency regulatory meeting, committees and trade associations. Remains up to date on changing regulations, and...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$177k - $278.08k
...the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of...Minimum wageLocal areaRemote workWorldwide$154.4k - $242.55k
...information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the Role:As the Associate Director of HCP Branded Strategy and Marketing, you will be a champion of Takeda’s culture and values while leading the HCP branded strategy for...Minimum wageFixed term contractTerm timeLocal areaRemote work$120k - $135k
....Discover your purpose. Embrace innovation. Experience #LifeatRealChem.Job Summary:Real Chemistry is looking for an Associate Director, Medical Strategy tojoin our growing team!Our Associate Directors play a pivotal role in guiding the direction of projects and aligning...Work at officeLocal areaRemote work2 days per week$154.4k - $242.55k
...information I submit in my employment application is true to the best of my knowledge.Job DescriptionTakeda is hiring 3Associate Directors, HCP Branded Strategy and Marketing, Rheumatology located in Cambridge, MA. In these roles, you will be a champion of Takeda’s culture and...Minimum wageLocal area$175.35k - $219.2k
...About the Job: The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities...$140k - $200k
...Associate Director, Regulatory Project ManagementBoston, MACentessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical... ....Regulatory Communication: Coordinate with Regulatory Strategy Lead to manage interactions with global health...Full timeWorldwide
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