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Document Control Specialist, Regulatory Affairs
Support regulatory compliance efforts and manage documentation processes. This role ensures that all regulatory submissions, product labels, and quality documentation adhere to industry regulations, including FDA, cGMP, and international guidelines. The ideal candidate will have experience in document control, regulatory filings, and working within a highly regulated environment.
Responsibilities
Maintain and organize regulatory documents, including SOPs, product dossiers, ingredient specifications, and safety data sheets.
Ensure compliance with FDA, NSF, cGMP, and other applicable regulatory requirements for dietary supplements and functional foods.
Support the preparation, review, and submission of regulatory filings, notifications, and product registrations.
Collaborate with cross-functional teams (R&D, Quality, Operations) to ensure documentation accuracy and compliance.
Oversee the document control system, ensuring proper version control, approvals, and accessibility.
Review product labels and marketing materials for regulatory compliance.
Assist in audits and inspections by regulatory agencies and third-party certifiers.
Stay updated on regulatory changes and industry best practices to ensure continued compliance.
Essential Skills
Bachelor’s degree in a relevant field (Regulatory Affairs, Food Science, Biology, Chemistry, or related discipline).
2+ years of experience in regulatory affairs, document control, or quality compliance within the nutraceutical, food, or pharmaceutical industry.
Knowledge of FDA regulations, cGMP requirements, and labeling laws for dietary supplements.
Experience with electronic document management systems (EDMS) preferred.
Strong attention to detail and organizational skills.
Excellent communication and collaboration abilities.
Ability to manage multiple priorities in a fast-paced environment.
Additional Skills & Qualifications
Experience with dietary supplements and functional foods.
Familiarity with NSF, NDI, and other applicable regulatory standards.
Knowledge of fish oils and other nutraceutical products.
Work Environment
This is a 100% on-site role, working Monday through Friday from 8am to 4:30pm. You will be part of the Quality Department, which consists of approximately 20 individuals. The dress code is business casual. The position reports to the QA Manager.
Pay and Benefits
The pay range for this position is $70000.00 - $85000.00/yr.
You will be eligible to enroll in the Company’s health plan 30 days after hire, and the Company will cover most of the individual cost of the premium based on the individual plan you choose. Further, you will be entitled to participate in the Company’s 401k plan after three full months of employment. Finally, you will be eligible for 15 days of PTO per year. These 15 days will be accrued during your first year of employment. Every three months of work you will accrue one week. As of January 1st of 2026, your 15 days will be available.
Workplace Type
This is a fully onsite position in Clifton,NJ.
Application Deadline
This position is anticipated to close on Mar 21, 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.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.