Senior Manager, Regulatory Project Management

Role Summary

The Senior Manager, Regulatory Project Management leads regulatory-focused project management across the R&D lifecycle, supporting high-impact regulatory activities for key development milestones and global expansions. Reports to the Sr. Director of Regulatory Technology and Operations and partners with Global/Regional Regulatory Leads, Regulatory Operations, and cross-functional filing teams to facilitate timely submissions of high-quality data packages to US, EU, and global health authorities. This role is based in Cambridge, MA or Philadelphia, PA.

Responsibilities

• Lead regulatory-focused project management activities across the R&D product lifecycle, including global expansion.
• Develop and continuously optimize detailed regulatory project plans and timelines in close collaboration with the Global Regulatory Lead, Regulatory Operations, and sub-team leads.
• Identify and manage project interdependencies to ensure alignment across functions and understand critical path activities.
• Maintain real-time filing timelines and track key submissions/deliverables from investigational and marketing applications to registration.
• Interface with filing sub-teams to ensure mutual understanding and agreement on submission timelines and deliverables.
• Plan and facilitate cross-functional meetings/workshops (e.g., filing kick-off) to drive execution of submission strategies.
• Facilitate and co-lead critical filing team and sub-team meetings, ensuring follow-through on project deliverables and action items across the relevant expertise areas (e.g., nonclinical, CMC, clinical, regulatory functions).
• Ensure development of document reviewer/approver matrices and coordinate review cycles and roundtables aligned with submission timelines.
• Maintain comprehensive project dashboard(s) to communicate progress, risks, and key updates to teams and senior management.
• Proactively identify and escalate risks related to resources, timing, and deliverables as appropriate.
• Coordinate lessons learned sessions and facilitate implementation of feedback for process improvement.
• Contribute to the development and refinement of best practices and standardized processes for key regulatory submissions.

Qualifications

• Demonstrated project management skills with strong ability to prioritize multiple projects. Formal project management training is a plus.
• Proficiency in project management tools (e.g., Smartsheet, MS Project) and content management systems. Experience with timeline visual tools (OnePager, Think-Cell, Office Timeline, or similar) is a plus.
• Experience managing global regulatory submissions for initial investigational and/or marketing applications, including response to health authority questions.
• Understanding of regulatory processes, requirements and experience in interpretation of Health Authority guidelines.
• Ability to work both independently and collaboratively within a matrixed, cross-functional environment, leveraging strong interpersonal skills to build effective partnerships across departments and levels.
• Excellent written and verbal communication skills, including negotiation skills.
• Excellent organizational and meeting management/facilitation skills.
• Ability to problem solve, identify bottlenecks, and escalate issues appropriately in a timely fashion.
• Detail-oriented with a strong sense of accountability and urgency.

Education

• Bachelor's degree in life sciences, pharmacy, or related field preferred; at least 6 years’ experience in regulatory affairs or project management within the pharmaceutical or biotech industry.