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Regulatory Affairs Specialist

hace 2 meses

Xico, México Colgate-Palmolive A tiempo completo

Job Summary

This position will play a crucial role in maintaining product compliance throughout the entire product lifecycle, ensuring that all regulatory requirements are met for various product categories and regions. The successful candidate will be responsible for delivering high-quality dossiers for Latin America, primarily for cosmetics and household products.

Key Responsibilities

  • Compile and manage documents and information required for successful submissions, license renewals, and annual registrations.
  • Assist in the preparation of product dossiers regionally, ensuring accurate archiving of documents and timely updates to regulatory databases.
  • Stay up-to-date with regulations and requirements for Mexico and the Latin America region, providing guidance to business teams on strategic initiatives.
  • Lead process simplification and harmonization activities to improve efficiency within the Regulatory Operations team.
  • Alert Regional Regulatory Affairs managers of upcoming renewals and commitments in a timely manner.
  • Report regularly on progress to the Regional Regulatory Affairs Department, highlighting key performance indicators (KPIs) such as timelines and dossier preparation.
  • Collaborate with other regions to obtain necessary documents and information for product dossiers.
  • Assist in the preparation of Regulatory Standard Operation Procedures and track revision dates.
  • Collect documentation to support regulatory submissions in other countries for cross-border sourced products.
  • Artwork Approval:
    • Assist Regional Regulatory Affairs managers in creating ingredient lists for labeling purposes.
    • Assist RA managers with artwork review and approval.

Requirements

  • BS degree in Pharmacy, Chemical Pharmaceutical, or a related field.
  • 3-4+ years of experience in regulatory affairs, managing formulated products, quality, or product development in the pharmaceutical, medical devices, or similar industries.
  • Understanding of registration and regulatory requirements for cosmetics, household products, medical devices, and pharmaceutical products.
  • Knowledge of industry practices, techniques, and standards.
  • Excellent written and verbal communication skills, with good interpersonal skills.
  • Good planning and organizing skills, attention to detail, and a sense of urgency.
  • Ability to work under stress and meet deadlines.
  • Fluency in spoken and written Spanish is mandatory.
  • Advanced English level.
  • Good skills in Portuguese language are a plus.