Job Description
Director, Regulatory Affairs Operations
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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.
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This position is based at our Waltham, MA site in the Boston metropolitan area.
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Responsibilities
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Regulatory Submission Strategy & Planning
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- 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.
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Submission Management & Execution
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- 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.
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Cross-Functional Collaboration
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- 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.
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Vendor & Outsourcing Management
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- 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.
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Education, Skills & Experience
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- 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.
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