Senior Manager, Regulatory Project Management

Role Summary

The Senior Manager of Regulatory Project Management will report to the Sr. Director of Regulatory Technology and Operations. This role will develop and implement best practices for key regulatory submissions across the development lifecycle, including global expansions, and will support high-impact regulatory activities for key milestones and corporate goals. The role collaborates with Global and 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. Location: 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

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