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Regulatory Affairs Manager

Arch Staffing & Consulting

New York (NY)

Hybrid

USD 80,000 - 120,000

Full time

20 days ago

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Job summary

An established industry player seeks a Senior Regulatory Affairs Manager to ensure compliance of cosmetic and OTC products in North America. This role involves overseeing regulatory submissions, maintaining ingredient policies, and communicating emerging regulations to stakeholders. The ideal candidate will have over 8 years of experience in Regulatory Affairs, particularly in skin and personal care, and a proven track record of adhering to compliance requirements. Join a dynamic team dedicated to creating innovative products that enhance beauty and well-being, and help shape the future of consumer marketing in the lifestyle and culture sector.

Qualifications

  • 8+ years in Regulatory Affairs, preferably in skin and personal care products.
  • Strong communication skills and ability to work independently or in teams.

Responsibilities

  • Ensure regulatory compliance for cosmetic and OTC products from brief to launch.
  • Review and approve product claims, labeling, and advertising.

Skills

Regulatory Affairs
Regulatory Compliance
Written Communication
Project Management
Analytical Skills

Tools

MS Office Suite

Job description

  • Work Authorization: Candidate must be a US Citizen or Green Card Holder
  • Remote Options: Temporary Hybrid – 3 days in the office
  • Critical Skill required:

Summary:

Our client is a leading company in lifestyle and culture that helps our customers realize their beauty and dreams. We share our core values Beautiful, Healthy, and Refreshing with our customers. As a creative consumer marketing company, we go beyond the boundaries of conventional household goods and cosmetics to introduce creative products and services based on our customers' needs.

About the role:

The Senior Regulatory Affairs Manager ensures regulatory compliance of company’s US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Specifically, the Sr. 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 US portfolio in NA.

  • 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’s ingredient policies and appropriate product regulations.
  • Ensure claims are compliant with the company’s 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.

Minimum Qualifications:

  • Over 8 years of Regulatory Affairs and Regulatory Compliance experience within a regulated industry, preferably skin and personal care products, including OTC.
  • Product development experience is 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).
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