Senior Director, Global Regulatory Submissions & Operations

Meet Life Sciences; Boston (MA); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Competitive salary

Bonus

Equity

Benefits package

Job summary

A leading biotechnology company in Boston is seeking a Senior Manager for Regulatory Affairs Operations. In this hybrid role, you will lead global regulatory submissions and collaborate across teams to ensure timely delivery of regulatory documents. The ideal candidate has 6+ years of regulatory affairs experience, strong skills in eCTD publishing, and works well in cross-functional settings. This position offers competitive compensation and the opportunity to contribute to innovative oncology therapies.

Qualifications

• 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.

Responsibilities

• Act as Regulatory Operations Lead for submission planning and execution.
• Coordinate and manage global regulatory submissions (IND, CTA, NDA).
• Ensure regulatory documentation meets global eCTD submission standards.

Skills

Global regulatory submissions

eCTD publishing

Regulatory information management systems

Cross-functional collaboration

Project coordination

Education

Bachelor's or Master's degree in a life sciences discipline

Tools

Veeva RIM

Job description

A leading biotechnology company in Boston is seeking a Senior Manager for Regulatory Affairs Operations. In this hybrid role, you will lead global regulatory submissions and collaborate across teams to ensure timely delivery of regulatory documents. The ideal candidate has 6+ years of regulatory affairs experience, strong skills in eCTD publishing, and works well in cross-functional settings. This position offers competitive compensation and the opportunity to contribute to innovative oncology therapies.