Regulatory Affairs Specialist

hace 1 día


Xico, México Fenixfarma Mexico City, Mexico A tiempo completo
Regulatory Affairs Coordinator Job Description

Fenixfarma Mexico City, Mexico is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with local health regulations and leading a team of regulatory specialists to define strategies for product approvals.

Key Responsibilities:
  • Connect between companies/manufacturer and regulatory authorities ensuring compliance with legislation.
  • Obtain registration of new medicines and maintain existing registrations, including labelling and packaging updates.
  • Prepare responses to customer requests for information and review clinical protocols.
  • Ensure compliance with applicable regulations and develop processes for licensing and permits.
  • Check patent expiration dates and ensure registration compliance.
  • Work on registration of FDF (finished dosage formulation) and API (Active Pharmaceutical Ingredients).
Requirements:
  • Minimum: Bachelor's degree in Health Sciences in pharmaceutical area.
  • Desirable: Postgraduate.
  • Advanced English.
  • Experience in Regulatory Affairs (3+ years) at an operational level.
  • Desirable experience with staff in charge (2-3 years).
What We Offer:
  • Diligent, smart, independent, and able to work under pressure.
  • Full-time position with a competitive salary and benefits package.
  • Opportunities for professional growth and development.


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