• Senior Specialist, CMC Regulatory Affairs

    Actalent (Bothell, WA)


    Description

    + Support preparation, review, and submission of CMC sections for U.S. and global regulatory filings, including INDs/CTAs, amendments, and BLAs/MAAs.

    + Coordinate with internal stakeholders to gather technical information and ensure accuracy and consistency across CMC documentation.

    + Assist in developing and maintaining submission plans for assigned programs.

    + Review change controls and manufacturing documentation to assess regulatory impact.

    + Track and interpret evolving regulatory requirements and guidance relevant to cell and gene therapy manufacturing, testing, and control.

    + Support interactions with domestic and global health authorities, including preparation of meeting materials, responses to information requests, and briefing documents.

    + Maintain regulatory databases, document systems, and submission archives in compliance with internal procedures.

    + Contribute to continuous improvement initiatives within the Regulatory Affairs CMC function.

     

    Additional Skills & Qualifications

     

    + 3 years of experience supporting Regulatory Affairs and/or CMC functions in the Biotechnology industry.

    + Relevant experience with lentiviral vectors, cell and gene therapy process development and/or analytical method development.

    + Understanding of FDA regulations, and ICH GCP guidelines.

    + Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills.

    + Excellent attention to detail and demonstrated project management skills.

    + Ability to work independently and collaboratively among cross-functional teams.

    + Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities.

    + BA/BSc in a scientific field with a minimum of 5 years’ experience; or

    + MBA or MSc with a minimum of 2 years’ experience

    Pay and Benefits

    The pay range for this position is $67.31 - $72.12/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 hybrid position in Bothell,WA.

     

    Application Deadline

     

    This position is anticipated to close on Nov 13, 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.