Regulatory Affairs Director

2 days ago


Paranaque City, Calabarzon, Philippines Cobden & Carter International Full time
Job Title: Regulatory Affairs Head

Cobden & Carter International is seeking a highly skilled and experienced Regulatory Affairs Head to lead our Regulatory Affairs team in ensuring compliance with applicable regulations in the Philippines.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with FDA Philippines regulations and international standards.
  • Oversee the preparation, submission, and approval of product registrations and renewals.
  • Establish and maintain relationships with regulatory agencies, including the FDA Philippines.
  • Collaborate with cross-functional teams to ensure regulatory requirements are met at all stages of product development and commercialization.
  • Manage the regulatory aspects of product registration, ensuring timely renewals and compliance.
  • Lead and mentor the Regulatory Affairs team, ensuring high performance and regulatory expertise.
  • Identify and mitigate regulatory risks to ensure continued product compliance and market access.
Requirements:
  • Must be a licensed pharmacist in the Philippines.
  • Bachelor's degree in Pharmacy or a related field. A Master's degree or regulatory certification is preferred.
  • At least 7-10 years of experience in Regulatory Affairs, with a minimum of 3-5 years in a leadership role, preferably in the pharmaceutical industry.
  • Comprehensive knowledge of FDA Philippines regulations and international regulatory guidelines.
  • Proven track record of successful product registrations and interactions with regulatory agencies.
Work Setup:

Location: Paranaque

Set-up: Onsite 100%

Shift: Dayshift



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