Quality Assurance Regulatory Compliance

Quality Assurance Regulatory Compliance Specialist

The Quality Assurance Regulatory Compliance Specialist oversees regulatory affairs activities for a contract development and manufacturing organization (CDMO) that supports sterile injectable products from clinical through commercial phases. This role manages a broad spectrum of regulatory projects to support both internal operations and client needs, working closely with all internal departments as well as external clients, suppliers, contractors, and regulatory agencies. The position does not include direct supervisory responsibilities and requires on-site work rather than remote arrangements.

Responsibilities include overseeing regulatory affairs activities for sterile injectable products across clinical through commercial phases within a CDMO environment, maintaining current knowledge of all relevant regulations, accessing, interpreting, and communicating regulatory requirements to internal and external stakeholders, providing regulatory CMC support to clients, submitting and maintaining letters of authorization, maintaining and managing FDA establishment registrations and product listings, generating and maintaining NDC codes for FDA-approved commercial products, facilitating client quality agreements, preparing and submitting annual GDUFA self-identification documentation to the FDA, maintaining the Type V Drug Master File for sterile processing facilities, maintaining Site Master Files for the organizations facilities, supporting business development due diligence, developing, implementing, and maintaining standard operating procedures, performing regulatory assessments, writing, revising, and reviewing departmental SOPs, standard work instructions, and associated regulatory documents, supporting regulatory agency, customer, and vendor audits, collaborating with cross-functional teams, preparing and coordinating regulatory correspondence and documentation to support submissions and responses to regulatory authorities.

Essential skills include a Bachelors degree in Life Sciences or a related field, at least 5 years of experience in a regulated pharmaceutical or medical device industry with hands-on experience in regulatory affairs and increasing levels of responsibility, working knowledge of regulatory requirements, including FDA, ICH regulations, and GDUFA, with familiarity in regulatory submissions for INDs, ANDAs, NDAs, DMFs, CRL/DRL/IR ANDA responses, EU variation review responses, post-approval supplements, and pre-submission meeting packages, strong understanding of regulatory science and submission data requirements across all phases of product development for sterile parenteral products, knowledge of cGMP, ICH, and USP regulations or guidelines and their application in a regulated manufacturing environment, demonstrated ability to maintain and interpret complex regulatory frameworks such as 21 CFR Parts 11, 210, 211, 600, 820 and EudraLex Volume 4, excellent technical writing skills, with the ability to draft clear, accurate, and compliant regulatory documents and SOPs, prior experience preparing correspondence to the FDA and other regulatory authorities, ability to communicate regulatory requirements effectively to cross-functional teams and external partners, strong organizational skills with the ability to manage multiple regulatory projects and deadlines simultaneously.

Additional skills and qualifications include experience working within a contract development and manufacturing organization (CDMO) environment, familiarity with managing FDA establishment registrations, NDC and SPL listings, and NDC code generation for commercial products, experience maintaining Drug Master Files, including Type V DMFs, and preparing amendments and annual reports, experience maintaining Site Master Files for pharmaceutical facilities, exposure to supporting business development activities through regulatory due diligence and assessment of new business opportunities, experience developing and maintaining regulatory SOPs, work instructions, and training materials, comfort working closely with clients, suppliers, contractors, and regulatory agencies in a collaborative and service-oriented manner, ability to support and participate in agency, customer, and vendor audits, attention to detail and a high level of accuracy in regulatory documentation and data management, strong problem-solving skills and the ability to assess regulatory impact within a holistic change control framework.

The role is based in an office environment within a regulated pharmaceutical setting and is not a remote position. The specialist works on-site in close collaboration with quality, manufacturing, business development, and other internal departments, as well as with external clients, suppliers, contractors, and regulatory agencies. The work involves extensive use of computer systems and documentation tools to manage regulatory submissions, SOPs, and compliance records. The environment emphasizes adherence to cGMP and other regulatory standards, with a focus on accuracy, documentation control, and audit readiness.

This is a Contract to Hire position based out of Grand Rapids, MI. The pay range for this position is $40.00 - $52.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 position is anticipated to close on Oct 31, 2026. This is a fully onsite position in Grand Rapids,MI.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

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 process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.