Senior Manager, Regulatory Project Management and Operations

The Senior Manager of Regulatory Project Management and Operations is responsible for leading the planning, coordination, and delivery of high-quality regulatory submissions to global health authorities. This role ensures submission readiness, operational excellence, and compliance across cross-functional teams. The ideal candidate has strong project management capabilities, extensive experience with eCTD submissions, and the ability to navigate complex regulatory requirements in a fast-paced environment. This role will be based at our Waltham, MA site in the Boston metro area, with flexible on-site work arrangements.

Responsibilities

Regulatory Submission Strategy & Planning

• Lead end-to-end submission planning for investigational and marketing applications.
• Assess submission risks and develop mitigation plans to ensure on-time delivery.
• Partner with Regulatory Lead to define submission strategy, timelines, and deliverables.

Submission Management & Execution

• Manage content planning, authoring assignments, and cross-functional review cycles.
• Oversee the compilation, formatting, and publishing of regulatory documents in compliance with global eCTD requirements.

Cross-Functional Collaboration

• Act as the operational hub for regulatory submissions, facilitating communication across Regulatory, Clinical, Nonclinical, CMC, Program Management, and other functional teams.
• Drive submission team meetings, track progress, and mitigate risks.
• Establish clear roles, responsibilities, and timelines for team members.

Vendor & Outsourcing Management

• Manage interactions with external partners to ensure high-quality, timely filing.
• Evaluate vendor performance and implement process improvements as needed.

Requirements, Education, Experience & Skills:

• Bachelor’s degree in a scientific discipline
• 7+ years of regulatory submissions experience within the biotechnology or pharmaceutical industry.
• Proven track record managing major submissions (e.g., IND/CTA, NDA/BLA/MAA).
• Strong project management skills, with the ability to lead complex, cross-functional workstreams.
• In-depth knowledge of eCTD structure, global submission requirements, and electronic publishing systems.
• Strong project management skills, with the ability to lead complex, cross-functional workstreams.
• Excellent communication, organization, and attention to detail.