Regulatory Operations Director, Global Submissions & RIM

Pretzeltx; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Base salary

Bonus eligibility

Stock options

Health coverage

Dental coverage

Vision coverage

401(k)

Paid time off

Company holidays

Winter shutdown

Job summary

Pretzel Therapeutics in Boston seeks a Director, Regulatory Affairs Operations to lead Regulatory Operations as the company scales. You will own the RIM system, oversee global submissions, and build the future Regulatory Operations team.

This role partners with IT, QA, Clinical Development, CMC, and Regulatory Affairs to create governance, drive automation, and ensure inspection readiness across product lifecycles.

A strategic builder with 10–12 years of industry experience is preferred.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related discipline.
• Minimum 10–12 years of Regulatory Affairs/Operations experience in biotech/pharma.
• Experience leading RIM system implementation and regulatory submissions.

Responsibilities

• Lead the implementation, integration, and governance of the RIM platform.
• Oversee global regulatory submissions planning, publishing, and lifecycle activities.
• Develop a multi-year RIM roadmap aligned with company growth.

Skills

Regulatory operations

RIM implementation

Regulatory submissions

Cross-functional collaboration

Project governance

Inspection readiness

Education

Bachelor’s degree in Life Sciences or Regulatory Affairs

Advanced degree preferred

Tools

RIM system

eCTD publishing

Job description

Pretzel Therapeutics in Boston seeks a Director, Regulatory Affairs Operations to lead Regulatory Operations as the company scales. You will own the RIM system, oversee global submissions, and build the future Regulatory Operations team.

This role partners with IT, QA, Clinical Development, CMC, and Regulatory Affairs to create governance, drive automation, and ensure inspection readiness across product lifecycles.

A strategic builder with 10–12 years of industry experience is preferred.