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Regulatory Affairs Specialist

4 months ago

Palm Coast, United States DESIGNS FOR HEALTH INC Full time
Job DescriptionJob Description

Designs for Health is an industry-leading and rapidly growing manufacturer and distributor of nutritional supplements offered primarily through health care practitioners. By providing comprehensive support through our extensive product line, ongoing clinical education, and practice development programs, Designs for Health helps practitioners realize successful health outcomes for their patients. The company has two manufacturing plants and four distribution centers in the United States, and its products are distributed in five continents.


Position Overview

The Regulatory Affairs Specialist is responsible for supporting the Canada Regulatory and Quality Managers in obtaining and maintaining licenses and registrations in Canada. This individual would be involved in all aspects of the business including product development, commercialization, and post-market compliance for Natural Health Products.

Essential Job Duties

  • Helps, evaluate, review, prepare, submit, and maintain all applicable registrations/ amendments/ certifications for the business in Canada.
  • Helps maintain ingredient and product specifications to ensure they comply with Health Canada regulations.
  • Assists in the compliance review and approval of all Canadian marketed product labels and marketing literature in a timely manner.
  • Stays abreast of relevant industry regulations, guidelines, and best practices.
  • Provide regulatory support to customers, internal or external.
  • Support the importation of products in Canada.
  • Support Site License renewal in coordination with the Quality Manager as necessary.
  • Review, maintain and support product label approval in coordination with formula version and product license.
  • Coordinate and maintain Private label reviews and approval in coordination with DFH formula and label version.
  • Other Regulatory tasks, as assigned.

Competencies

  • Excellent organizational, planning, and problem-solving skills.
  • Experience in regulatory affairs registrations and/or filings.
  • Strong understanding of regulatory requirements in the dietary supplement industry
  • Professional and proactive demeanor and work ethic.
  • Strong interpersonal and communication skills, both written and verbal.
  • Ability to learn, use multiple systems/ software platforms to execute tasks.

Requirements

  • At least 4 years of Regulatory experience in nutraceuticals or similar industry and working with Health Canada.
  • Bachelor's degree in a related scientific field (e.g., Chemistry, Pharmacy, Food Science) or a relevant discipline.
  • Strong understanding of Health Canada's Natural Health Product Regulations, cGMP, and other relevant quality and regulatory standards.


Privacy

Your application for this position is subject to Designs for Health's Privacy Notice for Job Applicants and Workforce Members. Designs for Health does not sell your personal information, nor does Designs for Health share it for purposes of cross-context behavioral advertising.


Our Commitment to Diversity, Inclusion & Belonging
Designs for Health is an equal opportunity employer. We welcome diversity and are committed to creating an inclusive environment where all employees can grow and thrive. Our employees form meaningful and often life-long connections while working at Designs for Health. We are all passionate about our mission of designing a well world, together.