Senior Director Regulatory Affairs

Senior Manager – Regulatory Affairs Operations

Location - Cambridge, MA (Hybrid)

Oncology Biotech | Global Clinical Programs

I’m currently supporting an innovative clinical-stage biotechnology company developing next-generation therapies in oncology. With multiple clinical programs advancing globally, the organisation is expanding its Regulatory Affairs Operations capability to support an increasing number of regulatory submissions and interactions with global health authorities.

This is an opportunity to join a highly collaborative regulatory team and play a key role in driving operational excellence across global regulatory submissions.

The Role

Reporting into the Director of Regulatory Affairs Operations, you will provide hands‑on leadership across global regulatory submissions, supporting clinical development programs from early development through major filings.

You will work cross‑functionally with Regulatory Strategy, Clinical, CMC, and external partners to ensure submissions are delivered accurately and on time.

Key Responsibilities

• Act as Regulatory Operations Lead for submission planning and execution
• Coordinate and manage global regulatory submissions (IND, CTA, NDA and lifecycle updates)
• Ensure regulatory documentation meets global eCTD submission standards
• Support regulatory interactions with global health authorities
• Manage submission tracking, document control, and regulatory correspondence
• Provide expertise in publishing, QC, and regulatory technology platforms
• Partner with internal stakeholders to ensure regulatory readiness across clinical programs
• Contribute to the development of regulatory processes, standards, and best practices

Ideal Candidate Profile

• Bachelor’s or Master’s degree in a life sciences discipline
• ~6+ years of experience in Regulatory Affairs within pharma or biotech
• Strong experience with global regulatory submissions and eCTD publishing
• Hands‑on experience with regulatory information management systems (e.g., Veeva RIM)
• Experience supporting major submissions or lifecycle management activities
• Strong cross‑functional collaboration and project coordination skills

Why This Role?

• Join a high‑growth biotech with multiple clinical assets
• Highly visible role working across global regulatory programs
• Opportunity to influence submission strategy and operational processes
• Competitive salary, bonus, equity and benefits package

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