Associate Director, Regulatory Project Management
$150k - $214kRelay Therapeutics
The Opportunity Reporting to the Executive Director, Head of Regulatory Project Management, you will support the planning, coordination, and execution of complex global regulatory filings activities across the development portfolio. You will serve as a strategic partner to Regulatory Affairs leaders and cross-functional teams, ensuring regulatory strategies are translated into integrated, actionable plans that support successful health authority interactions and major submission milestones. You will facilitate alignment across functions, proactively identify risks and dependencies, and ensure teams remain focused on critical deliverables and timelines. You will play a key role in advancing Regulatory Project Management best practices, supporting operational excellence initiatives, and helping to build a scalable project management framework within the Regulatory function to support the company's growing portfolio. Your Role Lead regulatory project management activities for assigned development programs and major regulatory submission milestones. Partner with Global Regulatory Leads and cross-functional functional representatives to develop integrated submission and execution plans. Create, maintain, and communicate comprehensive project timelines, critical path, key milestones, risks, assumptions, and dependencies. Facilitate cross-functional team meetings, submission working groups, and external vendor/partner interactions to drive accountability and decision-making, track commitments, and ensure execution against key submission timelines Monitor project progress and provide clear status reporting to regulatory leadership and key stakeholders. Coordinate submission readiness activities, ensuring deliverables are developed, reviewed, approved, and completed according to established timelines. Partner with functional representatives to manage resource needs, workload forecasting, and prioritization of critical activities. Drive issue resolution and escalation processes to maintain project momentum and minimize delays. Contribute to the development and continuous improvement of Regulatory Project Management processes, tools, templates, metrics, and governance practices. Your Background Bachelor's degree in life sciences or related discipline required; advanced degree preferred. 8-10 years of biotechnology, pharmaceutical, or related industry experience, including significant regulatory affairs, project management, or drug development experience. Demonstrated experience managing cross-functional projects supporting regulatory submissions and development programs. Knowledge of regulatory submission planning, eCTD structure, content development, and filing readiness activities. Ability to operate effectively in a fast-paced, highly collaborative environment with competing priorities. Proficiency with project management tools and systems used to support regulatory planning and execution e.g. Smartsheet, Office Timeline. Estimated Salary Range: [$150,000 - $214,000].The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.#BP1 About Relay TherapeuticsRelay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!
$154.4k - $242.55k
...patient‑focused, innovation‑driven company that will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU within our Global Regulatory Affairs organization, based remotely....SuggestedMinimum wageFull timeLocal areaRemote workWorldwide- ...Associate Director supporting regulatory project management for development programs at a therapeutics company. Will coordinate complex global regulatory filings, align cross-functional teams on submission strategies, and maintain project timelines and risk tracking to...Suggested
$170.9k - $231.3k
...Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory... ...modalities, along with strong communication, collaboration, and project management skills. This individual will play an important role in...SuggestedFull timeTemporary workWork at officeLocal areaFlexible hours$170k - $195k
...? We are seeking a highly skilled Associate Director, Regulatory Affairs to support and help drive regulatory... ...to senior leadership and core project teams. Prepare company for FDA... ...outstanding communication and project management skills to juggle multiple priorities...SuggestedWork experience placementShift work- ...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ...Development, and Commercial project teams throughout clinical development and... ...supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product...SuggestedWorldwide
- Title: Associate Director, Global Regulatory Affairs Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen... ...& Technical Competencies Product/Project Leadership Provide regulatory input... ...proposed for project team and senior management decision making. Accountable for...Local areaWorldwide
$175k - $220k
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...Remote Reporting to Executive Director, Regulatory Science Orchard Therapeutics, a Kyowa... ...Track record of INDs preparation, management up to FDA clearance and maintenance... ...Experience in regulatory submission project management Previous experience in the...Odd jobLocal areaRemote work$167.65k - $207.1k
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# Associate Director, Clinical Development Project Manager - OncologyGSK · AnywhereFULL-TIMERemotePosted Sep 24, 2026## Job DescriptionBusiness Introduction... ...deliverables meet quality standards and adhere to regulatory and policy requirements. • Prepare the Stakeholder...For contractorsWork at officeLocal areaRemote work2 days per week3 days per week$180k - $205k
...The Role We are seeking a strategic, hands-on Associate Director, Regulatory Affairs to lead regulatory project teams and submission activities across assigned... ...standards. Proficiency with publishing and document management tools (e.g., Veeva, Smartsheet, Office Timeline...Work at office$135.3k - $202.9k
...the unimaginable with us. Scope The Associate Director, Global Regulatory Affairs Lead is responsible for the... ...and execution for their assigned projects in their region / country. Responsibilities... .... Partner with Regulatory Project Management and Submission Management. May act...Local areaRemote workMonday to FridayFlexible hours- Associate Director, Regulatory Affairs CMC (Project Management) Job Description Company Overview Founded over a decade ago,CRISPR Therapeuticsis a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The...Contract workRemote work
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...Work ® in 2026. Description of Role Centessa is seeking a Associate Director, Project Management - Orexin Development Programs . This individual will... ...preparation of documents to a quality standard required for Regulatory/Health Authority submissions Contribute to...Full timeFor contractors$170.9k - $231.3k
OverviewThe Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective... ...Lead and Regulatory Affairs management to lead and define regulatory strategy... ....Develop detailed regulatory project plans and support regulatory activities...Full timeTemporary workLocal areaWorldwideFlexible hours2 days per week- ...Description Job Description Title: Associate Director, Signal Management & Innovation Location: Cambridge... ...with Pharmacovigilance, Global Regulatory Affairs, Data Sciences, Medical Safety... ...vendors. Lead or support projects related to signal management processes...Remote job
$175k - $225k
...ScholarRock on X and on LinkedIn. Summary of Position: The Associate Director, Regulatory Strategy, is responsible for the development and... ...point of contact with regulatory authorities, leading and managing regulatory interactions, building trusted relationships with...Shift work$142.5k - $256.5k
## Associate Director, Regulatory Data Management & IntelligenceApplylocations: Cambridge, Massachusetts: Clinical Developmenttime type: Full timeposted... ...transformation initiatives, or regulatory data migration projects.* Experience partnering with Digital organizations to...Permanent employmentFor contractorsWork at officeWork from home$143k - $233k
Associate Director/Director, CMC Regulatory Cambridge, MA As part of the Pharmaceutical Development team, this position... ...and timelines in accordance with project goals Strong and deep foundational... ...regulatory affairs and/or program management, as applicable. Lead and manage...Contract workFor contractorsFor subcontractorWork at office$142.5k - $256.5k
The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements... ...documentation. Ability to work cross‑functionally and manage multiple projects in a fast‑paced environment. Strong attention to...Permanent employmentWork at officeWork from home$180k - $250k
...Title: Associate Director, Medical Affairs Company: Ipsen Biopharmaceuticals Inc. About... .... Support clinical research projects, including the design, execution, and analysis... ..., in coordination with the Grants Manager. In collaboration with the Medical Communications...Temporary workLocal areaFlexible hours- Takeda Pharmaceutical Co. is seeking an Associate Director to drive regulatory business systems and capability strategy from Boston, MA. You will translate... ...with regulatory systems will help shape roadmaps, manage demand, and foster process improvements across global teams...
$160.8k - $201k
...benefits, see our website: The Importance of the Role The Associate Director, Regulatory Labeling and Disclosures, will be responsible for leading... ..., maintenance and results posting on Health Authority-managed databases worldwide (e.g., Clinicaltrials.gov, EudraCT)....Work at officeLocal areaImmediate startWorldwide$160k - $250k
...how often (in days) to receive an alert: Create Alert Associate Director, Global Search & Evaluation Facility: Business Development... ...within the metabolic space ~ Proven track‑record of project management, search and evaluation, business development or an equivalent...Local areaFlexible hours$152.7k - $267.3k
...acquisitions, as well as integration and alliance management. The Group Vice President (GVP) area... .... Works independently on specific projects, requiring guidance and input from manager... ...Cambridge, MA, US. Reports to the Sr. Director, Global Evaluation. The role will interact...Local areaFlexible hoursNight shift$160k - $228k
...The opportunity As Associate Director, Biostatistics, you will be accountable for delivery, integrity and quality... ..., Translational Medicine, Clinical Data Management, Pharmacovigilance, Regulatory and Project Management). You will lead/support the planning...Flexible hours- ...statistical issues in regulatory agency meetings. Leading... ...in professional associations, conferences, and publications... .... As an Associate Director, responsible for... ...with the potential to manage full-time staff.... ...communicate results to the project team, management, and...Full time
$218.12k - $264.31k
...Associate Director, Biostatistics Working with Us Challenging. Meaningful... ...results, and preparation of regulatory submissions. With... ...objectives, and contributes to project development strategy Defends... ...public release of information Manages multiple studies to ensure...Hourly payFull timeTemporary workPart timeFor contractorsSummer workWork at officeRemote workFlexible hoursShift work$138.6k - $257.4k
...Description Summary Job Title: Associate Director, Business Operations #LI-... ...operations, financial management, scientific communications,... ...business operations, strategy, project management, or... ...Management, Project Management, Regulatory Compliance, Results-Oriented...- 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...
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