Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Job Description

The Regulatory Affairs Specialist plays a crucial role in supporting US FDA applications (NDAs, ANDAs, DMFs) and international drug product applications. This position involves planning, authoring, compiling, and submitting statutory reports in eCTD format for marketed products according to FDA requirements. The role also includes reviewing and assessing CMC regulatory impacts of post-approval changes and providing regulatory strategies.

Responsibilities

• Plan, author, compile, and submit statutory reports in eCTD format for marketed products per FDA requirements.
• Review and assess CMC regulatory impact of post-approval changes proposed at the manufacturing site and provide regulatory strategy.
• Plan, author, compile, submit, and manage variations and supplements for marketed products within and outside the United States.
• Participate in cross-functional teams and provide health authority requirements needed for support of post-approval changes.
• Author and review updates to marketed product labeling.
• Maintain regulatory knowledge of current guidelines and regulations.
• Maintain current regulatory databases and produce various reports as needed.
• Utilize and support electronic document management systems.
• Provide mentorship for entry-level regulatory associates.
• Understand and identify potential regulatory risks and recommend strategies based on current FDA/health authority requirements.
• Manage multiple priorities and critically review documentation for regulatory submissions, providing input for necessary revisions.

Essential Skills

• Experience with regulatory affairs, regulatory submissions, and regulatory documents.
• Familiarity with FDA regulations and pharmaceutical industry standards.
• Competence in CMC (Chemistry, Manufacturing, and Controls) processes.
• Ability to author, organize, and prepare electronic (eCTD) regulatory filings.
• Capability to understand and interpret FDA guidance and quality systems.

Additional Skills & Qualifications

• A minimum of 3 years experience supporting filings within regulatory, preferably in the pharmaceutical industry.
• Experience with any change control software.
• Strong analytical and strategic thinking skills.

Work Environment

The position is based in a standard office environment, requiring a willingness to work in a team-based setting. Flexibility to work outside regular hours is required.

This is a Contract position based out of St. Louis, MO.

The pay range for this position is $32.00 - $37.00/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)

This is a fully onsite position in St. Louis,MO.

This position is anticipated to close on Feb 28, 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.