Senior Level Regulatory Project Manager Jobs
Senior level regulatory project manager jobs place experienced professionals in charge of regulatory strategy, end-to-end program ownership, and the cross-functional teams that deliver compliant outcomes. Openings concentrate across Biotechnology & Pharmaceuticals and Consulting & Professional Services, with a mix of on-site, remote, and hybrid settings, and employers like Revolution Medicines, Insmed, and Burns & McDonnell hiring at this level now.
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Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
THE OPPORTUNITY
The Associate Director, Global Regulatory Affairs Project Management is an integral part of the global Regulatory Affairs organization and is responsible for translating global regulatory strategies into actionable execution plans. This role applies advanced project management expertise and operational leadership to guide cross-functional teams, supporting planned and ongoing drug marketing applications across RevMed programs. The role partners closely with Global Regulatory Science and Global Filing and Registration and contributes to the broader Global Regulatory Affairs function at RevMed. This position reports to the Senior Director, Global Regulatory Affairs Project Management. The ideal candidate will have an in-depth understanding of oncology drug development and demonstrated hands-on regulatory project management experience supporting early- and late-stage registrational programs, including the execution of global new drug marketing applications, in alignment with corporate objectives.
CORE RESPONSIBILITIES:
- Project manages regulatory submissions from initiation through submission, supporting the definition of scope, timelines, prioritization, resource needs, and key deliverables.
- Develop, maintain, and track comprehensive submission timelines for INDs / CTAs, NDAs / MAAs, amendments, agency interactions, and other key global regulatory activities.
- Partner with Global and Regional Regulatory Science Leads to advance global regulatory strategies for assigned molecules across indications.
- Facilitate Global Regulatory Teams and meetings to ensure coordinated development and execution of high-quality, timely global regulatory deliverables at the study level.
- Partner with Global Filing Leads on planning, resourcing, and execution of new drug marketing applications for global agency submissions, interactions, and approvals.
- Drive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead’s strategic vision.
- Coordinate with global partners to maintain consistent regulatory program plans, ensuring alignment, compliance, and continuity across regions.
- Proactively identify operational risks, gaps, and bottlenecks; propose and implement solutions, including process improvements and outsourcing strategies, as appropriate.
- Build and maintain submission dashboards; communicate status, risks, and mitigation strategies to senior management and key stakeholders.
- Support the development, implementation, and continuous improvement of global regulatory project management processes, templates, tools, dashboards, analytics, and best practices.
- Champion innovation and operational excellence, identifying opportunities to streamline regulatory project management and enhance submission preparation efficiency and scalability.
BASIC QUALIFICATIONS:
- Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
- 12+ years of pharma / biotech industry experience, including 6-8+ years of regulatory project management experience. Hands-on U.S. drug marketing application experience required.
- Strong working knowledge of global regulatory regulations, guidelines, and submission pathways; familiarity with nonclinical, clinical, and CMC (bio)pharmaceutical development.
- In-depth knowledge of CTD structure and dossier component management, including coordination across cross-functional filing team contributors and senior leadership.
- Exceptional project management skills with proven ability to manage multiple complex programs under compressed timelines in a fast-paced, cross-functional environment that values both speed and quality.
- Excellent communication and interpersonal skills, with demonstrated ability to influence, manage group dynamics, and balance functional, team, and leadership objectives.
- Ability to think both strategically and tactically and present recommendations to senior leadership and key stakeholders.
- High proficiency with project management tools including Smartsheet and Microsoft Project, and familiarity with WBS management, timeline development, and critical path analysis; experience with OnePager, Office Timeline, and Veeva RIM is a plus.
PREFERRED QUALIFICATIONS:
- Experience supporting global regulatory filings including Japan, Canada, and EU / UK submissions.
- Oncology drug development experience.
- Experience with complex oncology clinical trial designs (e.g., combination studies, multi-cohort expansions, basket or umbrella master protocols).
COMPENSATION
- Base Pay Salary Range: $186,000 - $233,000 USD
Our base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.
INTRODUCTION
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
THE OPPORTUNITY
The Associate Director, Global Regulatory Affairs Project Management is an integral part of the global Regulatory Affairs organization and is responsible for translating global regulatory strategies into actionable execution plans. This role applies advanced project management expertise and operational leadership to guide cross-functional teams, supporting planned and ongoing drug marketing applications across RevMed programs. The role partners closely with Global Regulatory Science and Global Filing and Registration and contributes to the broader Global Regulatory Affairs function at RevMed. This position reports to the Senior Director, Global Regulatory Affairs Project Management. The ideal candidate will have an in-depth understanding of oncology drug development and demonstrated hands-on regulatory project management experience supporting early- and late-stage registrational programs, including the execution of global new drug marketing applications, in alignment with corporate objectives.
CORE RESPONSIBILITIES:
- Project manages regulatory submissions from initiation through submission, supporting the definition of scope, timelines, prioritization, resource needs, and key deliverables.
- Develop, maintain, and track comprehensive submission timelines for INDs / CTAs, NDAs / MAAs, amendments, agency interactions, and other key global regulatory activities.
- Partner with Global and Regional Regulatory Science Leads to advance global regulatory strategies for assigned molecules across indications.
- Facilitate Global Regulatory Teams and meetings to ensure coordinated development and execution of high-quality, timely global regulatory deliverables at the study level.
- Partner with Global Filing Leads on planning, resourcing, and execution of new drug marketing applications for global agency submissions, interactions, and approvals.
- Drive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead’s strategic vision.
- Coordinate with global partners to maintain consistent regulatory program plans, ensuring alignment, compliance, and continuity across regions.
- Proactively identify operational risks, gaps, and bottlenecks; propose and implement solutions, including process improvements and outsourcing strategies, as appropriate.
- Build and maintain submission dashboards; communicate status, risks, and mitigation strategies to senior management and key stakeholders.
- Support the development, implementation, and continuous improvement of global regulatory project management processes, templates, tools, dashboards, analytics, and best practices.
- Champion innovation and operational excellence, identifying opportunities to streamline regulatory project management and enhance submission preparation efficiency and scalability.
BASIC QUALIFICATIONS:
- Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
- 12+ years of pharma / biotech industry experience, including 6-8+ years of regulatory project management experience. Hands-on U.S. drug marketing application experience required.
- Strong working knowledge of global regulatory regulations, guidelines, and submission pathways; familiarity with nonclinical, clinical, and CMC (bio)pharmaceutical development.
- In-depth knowledge of CTD structure and dossier component management, including coordination across cross-functional filing team contributors and senior leadership.
- Exceptional project management skills with proven ability to manage multiple complex programs under compressed timelines in a fast-paced, cross-functional environment that values both speed and quality.
- Excellent communication and interpersonal skills, with demonstrated ability to influence, manage group dynamics, and balance functional, team, and leadership objectives.
- Ability to think both strategically and tactically and present recommendations to senior leadership and key stakeholders.
- High proficiency with project management tools including Smartsheet and Microsoft Project, and familiarity with WBS management, timeline development, and critical path analysis; experience with OnePager, Office Timeline, and Veeva RIM is a plus.
PREFERRED QUALIFICATIONS:
- Experience supporting global regulatory filings including Japan, Canada, and EU / UK submissions.
- Oncology drug development experience.
- Experience with complex oncology clinical trial designs (e.g., combination studies, multi-cohort expansions, basket or umbrella master protocols).
COMPENSATION
- Base Pay Salary Range: $186,000 - $233,000 USD
Our base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.
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Senior Level Regulatory Project Manager Jobs: Frequently Asked Questions
How do I get a senior level regulatory project manager job?
Employers at this level look for demonstrated ownership of complex regulatory submissions, agency interactions, and program timelines rather than task execution alone. A strong candidate brings a history of leading cross-functional teams through submissions or audits, fluency with frameworks like ICH, FDA, or EMA guidelines, and the ability to mentor junior staff. Highlighting outcomes you owned, not just contributed to, is what separates senior candidates from mid-level competition.
Which companies hire senior level regulatory project managers?
Companies hiring senior level regulatory project managers right now include Revolution Medicines, Insmed, and Burns & McDonnell, based on current listings on Migrate Mate as of November 2026. Hiring at this level tends to come from large pharmaceutical, medical device, and biotech firms, as well as contract research organizations and regulatory consulting groups managing multi-product portfolios.
Are there remote senior level regulatory project manager jobs?
Yes, though availability varies by employer and regulatory scope. About 0% of senior level regulatory project manager openings are remote or hybrid as of November 2026, reflecting the documentation-heavy, meeting-intensive nature of the work. Roles tied to lab oversight or on-site audits are more likely to require a physical presence, while submission management and strategic advisory positions often allow flexible arrangements.
What makes a regulatory project manager role senior level?
Senior level regulatory project manager roles are defined by scope, accountability, and leadership depth. Rather than executing tasks within a defined plan, senior professionals own the regulatory strategy across a product line or program, manage agency relationships directly, and are responsible for timelines and risk decisions. They typically mentor junior and mid-level staff, represent regulatory affairs in cross-functional leadership forums, and are expected to resolve ambiguity without escalation.
Which industries hire the most senior level regulatory project managers?
Senior level regulatory project manager roles concentrate in Biotechnology & Pharmaceuticals and Consulting & Professional Services, based on current listings on Migrate Mate as of November 2026. These sectors drive demand because they operate under strict agency oversight, maintain large product pipelines requiring ongoing submissions and renewals, and face significant compliance risk that justifies experienced regulatory leadership at the program level.