Manager, Regulatory Affairs

  • Company: Fresh
  • Location: United States
  • Business group: Perfumes & Cosmetics
  • Contract type: Permanent Job
  • Function: Legal
  • Experience required: Minimum 5 years
  • Reference No.: FRSH00153
  • Date of publication: 2019.02.15

Position

MAIN OBJECTIVE

The Manager, Regulatory Affairs will lead and ensure global regulatory compliance with internal and external standards by working with Central Regulatory Affairs based in France.  Reporting to the VP, Legal Counsel, and in close collaboration with the Central RA team, the Manager will drive and implement processes for performance improvement, liaise with local teams to ensure efficient regulatory review, and assess regulatory risks. 

 

RESPONSIBILITIES

  • Assess needs, set strategies, develop and maintain internal procedures for regulatory compliance, product safety and performance improvement, assist internal teams for implementation
  • Ensure efficient regulatory pre-review of artworks
  • Support Research & Innovation on validation of non-cosmetic products and OTC product development and compliance needs. Collaborate with Operations on issues related to regulatory quality, and provide guidance on compliance risks
  • Manage the relationships with authorities (e.g., FDA, Customs) and monitor the controls in collaboration with US Regulatory Affairs and central RA
  • Manage health-related complaints (cosmeto-vigilance) with R&I collaboration, to analyze, trend and recommend appropriate actions
  • Secure the business in easing International re-registrations, and contribute to follow up reformulations
  • Work cross functionally with broader business partners on new product developments. Perform product line reviews and attend status meetings with business partners
  • Assist with regulatory documentation and technical assistance to support pre-market registrations
  • Research safety and regulatory requirements in US and international markets to support global expansion (FDA, Health Canada, new markets, etc.). Determines requirements and reviews Vendor documentation and testing to support claims, all in conjunction with Central RA
  • Maintain understanding of cosmetic regulations, as it relates to ingredients and finished product
  • Gain working knowledge of safety, claims support and regulatory as part of the global regulatory team
  • Monitor regulatory KPIs

Profile

  • B.A. / B.S. required; degree in regulatory affairs, chemistry, engineering, life sciences, international business, or related field
  • Minimum of 5 years regulatory experience in the cosmetic industry
  • Demonstrated project management and organizational skills
  • Strong knowledge of the cosmetic industry, formulations, packaging, labelling and manufacturing practices.=
  • Solid knowledge of global cosmetic and drug product regulations and US state environmental regulations, as well as EU, Canada and Asia international cosmetic regulations
  • Global Regulations for Cosmetic, OTC and Consumer Products required
  • Experience in cosmetic product compliance and international product registrations
  • Experience interacting with governmental agencies
  • French language skills are desired but not required

Additional information

HOW TO APPLY:

Please include your resume and a short cover letter in .pdf format.

In your cover letter, provide two (2) examples demonstrating your superior organizational skills or keen attention to detail.

Apply

Perfumes & Cosmetics

A major player in the perfumes, make-up and skincare markets, the Perfumes & Cosmetics division groups together major historic Houses as well as young brands with strong potential.

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