Job Title: Quality Assurance Associate

Job Description

The Regulatory Affairs Specialist/Compliance Specialist/QA Specialist is responsible for overseeing regulatory affairs activities within a contract development and manufacturing organization. This role involves managing a wide range of projects to support regulatory needs for sterile injectable products, from clinical through commercial phases. The position requires interaction with all internal departments, external clients, suppliers, contractors, and regulatory agencies.

Responsibilities

• Maintain current knowledge of all relevant regulations, including 21CFR Parts 11, 210, 211, 600, and 820, and applicable guidance documents.
• Monitor regulatory changes that may impact manufactured products and communicate requirements to stakeholders.
• Provide regulatory CMC support to clients, ensuring submissions align with supply agreements.
• Submit and maintain letters of authorization for clients referencing a Type V Drug Master File.
• Manage FDA establishment registrations and product listings, including generating NDC codes for commercial products.
• Facilitate client quality agreements, ensuring alignment with regulatory requirements.
• Submit annual GDUFA self-identification(s) to the FDA.
• Maintain and manage the Type V Drug Master File, including amendments and annual reports.
• Maintain Site Master Files for facilities.
• Support business development due-diligence evaluation of new opportunities.
• Develop and maintain SOPs, work instructions, forms, and training materials related to Regulatory Affairs.
• Perform regulatory assessments for change control processes.
• Write, revise, and review 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.
• Hands-on experience in Regulatory Affairs with increasing responsibilities.
• Working knowledge of FDA/ICH regulations and familiarity with regulatory submissions.
• Knowledge of regulatory science and submission data requirements for sterile parenteral products.
• Understanding of cGMP, ICH, and USP regulations or guidelines.
• Excellent technical writing skills.
• Experience preparing FDA correspondence.

Additional Skills & Qualifications

• Familiarity with regulatory submissions for INDs, ANDAs, NDAs, DMFs, CRL/DRL/IR ANDA, EU variation review responses, post-approval supplements, and pre-submission meeting packages.

Work Environment

This position is based in an office environment and is not remote.

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 remote position.

Application Deadline

This position is anticipated to close on Aug 25, 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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $40 - $52