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R&D Regulatory Affairs Manager

Job title: R&D Regulatory Affairs Manager
Contract type: Full-time
Location: Englewood
Discipline:
Remote: No
Salary: $80,000/year - $120,000/year
Reference: 462836
Contact name: Nora Gillern

Job description

Our client is a leading beauty company that is looking for a new Regulatory Affairs Manager to join their team!

 

About the Role

The Regulatory Affairs Manager ensures regulatory compliance of the companies, OTC, dietary supplement, and device products from brief through launch in North America. Specifically, the Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising. Communicate emerging regulations to key stakeholders and their impact on the brand portfolio in NA.

 

You will report to the Sr. RA Manager.

 

Roles and responsibilities

  • Participate in project teams in assigned categories to ensure completion of appropriate documents during the development process through final formula approval and launch
  • Maintain and ensure compliance with the company ingredient policies and appropriate product regulations
  • Ensure claims are compliant with the company and local regulatory requirements and consistent across labels, advertising, and other consumer communications
  • Review and approve NA artworks
  • Responsible for US regulatory submissions, including FDA drug and establishment registrations, supplement notifications, WERCS and EPA and state pesticide registrations
  • Assist monitoring US state and federal regulations impacting the cosmetic and personal care industry including OTC
  • Support with upcoming changes in the regulations including any specific monitoring and implementation for states, e.g., California

 

Qualifications

  • Scientific degree preferred
  • Over 5 years of Regulatory Affairs experience within a regulated industry, preferably skin and personal care products including OTC.
  • Product development experience strongly preferred.
  • Skin and personal care including OTC claim review experience strongly preferred.
  • Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
  • Strong written communication skills, especially detail oriented and technical material.
  • Experience communicating with cross-functional teams and customers including verbal presentations.
  • Ability to work effectively both independently and as part of a team.
  • Ability to meet deadlines while being flexible to changes in priorities and interruptions.
  • Excellent organizational and analytical skills to complete assignments accurately.
  • Full usability of MS Office suite (Excel, Word, Outlook, Powerpoint)

 

Salary Range: $80 - $120k

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