As a Regulatory Operations Manager, you will be responsible for formatting and publishing electronic documents and constructing regulatory submission deliverables. You will ensure that submissions are of the highest quality and are delivered on time. Additionally, you will archive and track regulatory correspondences, documents, and submissions.

Responsibilities

Format and publish electronic documents for regulatory submissions.Build regulatory submission deliverables ensuring they meet quality standards.Ensure timely delivery of all submissions.Archive and track regulatory correspondences, documents, and submissions.

Essential Skills

5-7 years of experience in regulatory operations/submissions.Proficiency in eCTD publishing systems.Strong knowledge of FDA/EU/ICH guidelines related to regulatory submissions.

Additional Skills & Qualifications

Experience with the person RIM preferred.

Work Environment

This is a remote position. You will be part of a regulatory team consisting of 14 people.

Hours: Part-time (30 hours/week)

Job Type & Location

This is a Contract position based out of Lexington, MA.

Pay and Benefits

The pay range for this position is $75.00 - $85.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Feb 6, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.