Regulatory Affairs & Document Control Specialist

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Mackenzie Stuart
New Jersey, UNITED STATES, United States
  • Food
  • FullTime
  • Applications have closed

Mackenzie Stuart is partnered with a fast-growing nutraceutical contract manufacturer seeking a detail-oriented Regulatory Affairs & Document Control Specialist to support our 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.

*Please do not apply if you require via or sponsorship. Sadly, we cannot accommodate this on this occasion*

Job 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, NDI submissions, 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.

Requirements:

  • 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.

Mackenzie Stuart is a leading executive search and selection business. From our offices in Leeds & London, we provide retained and contingency recruitment solutions across industry and have specialist recruitment consultants that work within the Oil & Gas, Mining, Infrastructure & Built Environment, Medical & Scientific, Healthcare, Education, Finance & Accountancy, Insurance, Water, Chemicals, Ingredients & Flavours, Automation, FMCG, and Logistics sectors.

Due to the high volume of applicants, please assume your application has been unsuccessful if you do not hear from us within 14 days.

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