Director, Regulatory Operations

Director, Regulatory Affairs Operations

The Director of Regulatory Affairs Operations, with level commensurate with experience, will be responsible for planning, coordinating, and executing high-quality regulatory submissions to global health authorities. This role will ensure submission readiness, operational excellence, and compliance across cross-functional teams. The ideal candidate will bring strong project management expertise, extensive experience with eCTD submissions, and the ability to navigate complex regulatory requirements in a fast-paced biotechnology or pharmaceutical environment.

This position is based at our Waltham, MA site in the Boston metropolitan area.

Responsibilities

Regulatory Submission Strategy & Planning

• Partner with Regulatory and program leadership to develop and execute end-to-end submission plans for investigational and marketing applications.
• Define submission strategies, timelines, key deliverables, and operational milestones in collaboration with cross-functional leadership.
• Identify submission risks and develop proactive mitigation strategies to ensure timely and high-quality delivery.

Submission Management & Execution

• Lead content planning, authoring assignments, review cycles, and submission deliverables across functional teams.
• Oversee the compilation, formatting, quality control, and publishing of regulatory documents in accordance with global eCTD requirements.
• Monitor submission readiness and ensure all deliverables meet established quality, regulatory, and timeline expectations.

Cross-Functional Collaboration

• Serve as the operational hub for assigned regulatory submissions, coordinating activities across Regulatory, Clinical, Nonclinical, CMC, Program Management, and other functional teams.
• Lead submission team meetings, track deliverables and milestones, identify potential issues, and drive timely resolution of risks and dependencies.
• Establish and communicate clear roles, responsibilities, timelines, and expectations for submission team members.
• Foster effective collaboration and communication across functions to maintain submission momentum and readiness.

Vendor & Outsourcing Management

• Manage relationships with external vendors and partners supporting regulatory submissions to ensure high-quality and timely delivery.
• Monitor vendor performance, deliverables, and timelines, and address issues as they arise.
• Identify opportunities to improve vendor management and submission processes, implementing efficiencies and best practices as appropriate.

Education, Skills & Experience

• Bachelor’s degree in a scientific discipline or related field.
• 7 years of regulatory submissions experience within the biotechnology or pharmaceutical industry.
• Demonstrated experience managing major global regulatory submissions, including INDs/CTAs and marketing applications such as NDAs, BLAs, and MAAs.
• Strong project management skills, with demonstrated ability to lead complex, cross-functional workstreams and manage competing priorities.
• In-depth knowledge of eCTD structure, global regulatory submission requirements, and electronic publishing systems.
• Experience coordinating submission activities across multiple functions and managing critical timelines and dependencies.
• Excellent written and verbal communication skills, with the ability to effectively engage stakeholders at varying levels of the organization.
• Exceptional organizational skills, attention to detail, and ability to operate effectively in a fast-paced, deadline-driven environment.