Regulatory Affairs Director

4 days ago


Paranaque City, Calabarzon, Philippines Faberco Life Sciences Incorporated Full time

Faberco Life Sciences Incorporated seeks a highly skilled Regulatory Affairs professional to lead the team in ensuring pharmaceutical products comply with applicable regulations.

Job Description

The Head of Regulatory Affairs is responsible for overseeing regulatory submissions, managing relationships with regulatory agencies, and ensuring compliance with local and international laws.

Bold Key Responsibilities:

  • Ensure all products comply with FDA Philippines regulations and international standards.
  • Oversee product registrations and renewals, acting as primary contact with regulatory authorities.
  • Collaborate with BD and Marketing to ensure regulatory requirements are met throughout product development and commercialization.
  • Maintain accurate regulatory documentation and provide regular reports to senior management.
  • Lead and mentor the Regulatory Affairs team, ensuring high performance and regulatory expertise.

Key Accountabilities:

  • Regulatory Compliance
  • Regulatory Agency Relationship
  • Product Registration Management
  • Audit & Inspection Readiness

Requirements:

  1. Licensed pharmacist in the Philippines required.
  2. Bachelor's degree in Pharmacy or related field; Master's degree or regulatory certification preferred.
  3. At least 7-10 years of experience in Regulatory Affairs, with 3-5 years in leadership role, preferably in pharmaceutical industry.
  4. Comprehensive knowledge of FDA Philippines regulations and international guidelines.
  5. Proven track record of successful product registrations and interactions with regulatory agencies.
  6. Strong communication and negotiation skills.


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