Job Details

About Us

We are a preeminent regulatory management consulting firm serving companies in the Food/Beverage, Dietary Supplement, Cosmetic, and OTC/Homeopathic industries.

Position Summary

The QA Regulatory Manager in Quality DevelopmentServices (QDS) is responsible for project ownership, clients' support, as directed in areas of regulatory compliance: manufacturing operations, standard operating procedure writing/optimization, specification writing, auditing, training, product development support, regulatory due diligence, formulation reviews, regulatory operations compliance, quality documentation review/development, FSMA/HARPC Plan writing/reviews, cGMP Facility Audits as directed, safety data sheets, registrations in US markets, support for report drafting and reviews of reports and marketing copy, and aid the design and development of controlled documentation, as well as providing other support to colleagues as your skills permits and as required.

You will organize regulatory information, track and control documentation, proof-read and provide input on compliance works in accordance with daily operating practices and the regulations as cited under the applicable regulations relevant to the assigned projects.

Essential Duties and Responsibilities

• Write, review, collect, coordinate and/or oversee projects, and prepare regulatory documentation for submission to regulatory agencies, commercial partners and/or clients, including but not limited to SOP's, ingredient and finished product specifications, quality agreements, formulation reviews, quality program design/input, HACCP/HARPC Plans, FSMA Compliance, cGMP Training, and other investigation reports, study protocols, final reports reviews and submissions as directed.
• Define, manage and/or execute projects and prepare regulatory documentation for submission to regulatory agencies or to commercial partners and/or clients, including but not limited to regulatory plans, investigational reports, professional opinions, study protocols, final reports, and related data. Cooperate with team members on shared projects as designated to ensure efficiency in time management, execution of the work, and correctness of any deliverables or communications as designated.
• Maintain regulatory files/database and other systems in good order and in compliance with project or regulatory requirements.
• Review changes to existing product formulations and Quality Systems to help define the requirements for regulatory compliance of individual clients.
• Maintain regulatory and scientific excellence by keeping current knowledge of FTC, FDA, USDA and other national regulations, guidance, and standards applicable to client products upon direction and/or as experience permits.
• Actively participate in evaluation of regulatory changes affecting compliance of documentation, product(s), process(es) and methodologies.
• Provide team and client leadership with guidance on compliance matters and regulatory operations with respect to known strategies and activities.
• Operate seamlessly within team in a project management-driven environment to keep all projects updated/current, reporting of billable time, and proper utilization of company software and resources to ensure traceability and accountability.
• Participate as needed in tradeshows, conferences, and other industry-related events.
• Travel as needed/permitted to client facilities or other locations in direct support of assigned projects, or other company activities.

Knowledge, Skills, and Abilities

• Extensive knowledge in FDA, FTC, USDA regulations.
• Knowledge of FDA CFR 21 Part 11, Part 111 and Part 117.
• Must be able to handle multiple projects.
• Proficient in MS Team, Word, Excel and Adobe.

Education & Experience

• BS in a scientific field is required. MS, Ph.D. (preferred).
• Minimum of 12 years' experience in Quality Assurance within the OTC industry.
• Food & Beverage, Dietary Supplement, Cosmetic and/or Homeopathic industries as a bonus.