Regulatory Affairs Director

2 weeks ago


Paranaque City, Calabarzon, Philippines Cobden & Carter International Full time
Job Description:

Are you a seasoned Regulatory Affairs professional with a passion for ensuring pharmaceutical products comply with regulations? Do you have strong leadership skills and experience managing teams in the pharmaceutical industry?

About the Role:

We are seeking a highly experienced Regulatory Affairs Head to join our team at Cobden & Carter International. As a Regulatory Affairs Head, you will be responsible for leading and managing the Regulatory Affairs team in ensuring that all pharmaceutical products comply with applicable regulations in the Philippines.

Main Responsibilities:
  • Regulatory Compliance: Ensure all products and activities of the company comply with FDA Philippines regulations and international standards.
  • Regulatory Agency Relationship: Oversee the preparation, submission, and approval of product registrations and renewals, act as the primary contact with FDA Philippines and other regulatory authorities.
  • Product Registration Management: Work closely with BD and Marketing to ensure regulatory requirements are met at all stages of product development and commercialization.
  • Audit & Inspection Readiness: Maintain accurate and updated regulatory documentation and provide regular reports to senior management.
Requirements:
  • Must be a licensed pharmacist in the Philippines.
  • Bachelors degree in Pharmacy or a related field. A Masters 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

Estimated Salary: PHP 150,000 - PHP 200,000 per month (based on location and industry standards).



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