Senior Regulatory Affairs (RA) Manager - CODEFORCE 360 : Job Details

Senior Regulatory Affairs (RA) Manager

CODEFORCE 360

Job Location : New York,NY, USA

Posted on : 2024-09-19T07:22:27Z

Job Description :
Summary
  • 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 client 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 client portfolio in NA.
Roles & 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 client ingredient policies and appropriate product regulations
  • Ensure claims are compliant with The client 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
  • Scientific degree
  • Over 8 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)
Preferred Qualifications
  • Onsite 3 days per week
  • Bilingual English/Korean preferred
Apply Now!
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