• Regulatory Affairs Specialist

    Actalent (Grand Rapids, MI)


    Job Title: Regulatory Affairs SpecialistJob Description

     

    The Senior Regulatory Affairs Specialist/Compliance Specialist/QA Specialist oversees regulatory affairs activities for a contract development and manufacturing organization (CDMO), supporting sponsors and application/license holders for sterile injectable products from clinical through commercial phases. This role manages a broad spectrum of projects to support regulatory needs, interacting with all internal departments, external clients, suppliers, contractors, and regulatory agencies. This position does not include overseeing direct reports and is not remote.

    Responsibilities

    + Maintain current knowledge of all relevant regulations (21CFR Parts 11, 210, 211, 600, 820 and applicable guidance documents, EudraLex Volume 4) and monitor changes impacting manufactured products.

    + Access and communicate regulatory requirements to stakeholders to maintain compliance without business delays.

    + Provide regulatory CMC support, including document preparation for filings and reviewing client submissions.

    + Submit and maintain letters of authorizations for referencing a Type V Drug Master File in submissions.

    + Manage FDA establishment registrations and product listings, filing/obtaining new registrations as required.

    + Generate and maintain NDC codes for FDA approved commercial products for Cares Act Reporting.

    + Facilitate client quality agreements, ensuring alignment with regulatory requirements.

    + Submit annual GDUFA self-identifications to the FDA.

    + Maintain Type V Drug Master File and Site Master Files, including amendments and annual reports.

    + Support business development due-diligence evaluations and contribute to new-business selection.

    + Develop and maintain SOPs, work instructions, forms, and training materials related to Regulatory Affairs.

    + Perform Regulatory Assessments for the holistic change control process.

    + Write, revise, and review relevant departmental SOPs, SWIs, and associated documents.

    + Support agency, customer, and vendor audits as needed.

    Essential Skills

    + Bachelor’s degree in Life Sciences or a related field.

    + 5+ years of experience in a regulated pharmaceutical or medical device industry with hands-on Regulatory Affairs experience.

    + Working knowledge of FDA/ICH regulations, GDUFA, and familiarity with regulatory submissions for INDs, ANDAs, NDAs, and more.

    + Knowledge in regulatory science and submission data requirements for sterile parenteral products.

    + Understanding of cGMP, ICH, and USP regulations or guidelines.

    + Excellent technical writing skills.

    + Prior experience preparing FDA correspondence.

     

    Work Environment

     

    This position is based in an office environment.

     

    Job Type & Location

     

    This is a Contract position based out of Grand Rapids, Michigan.

    Pay and Benefits

    The pay range for this position is $40.00 - $52.00/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 onsite position in Grand Rapids,MI.

     

    Application Deadline

     

    This position is anticipated to close on Oct 29, 2025.

    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 [email protected] (%[email protected]) for other accommodation options.