Regulatory Affairs Director

3 weeks ago


Paranaque City, Calabarzon, Philippines Cobden & Carter International Full time
About the Role

The Regulatory Affairs Director will lead our team in ensuring compliance with pharmaceutical regulations in the Philippines.

Responsibilities
  • Oversee regulatory submissions and manage relationships with FDA Philippines.
  • Ensure product registrations and renewals comply with local and international laws.
  • Act as primary contact with regulatory authorities, including FDA Philippines.
  • Collaborate with Business Development and Marketing teams to ensure regulatory requirements are met.
  • Manage product registration, ensuring timely renewals and compliance.
  • Maintain accurate regulatory documentation and provide regular reports to senior management.
  • Lead and mentor the Regulatory Affairs team, promoting high performance and regulatory expertise.
Key Accountabilities
  • Regulatory Compliance
  • Regulatory Agency Relationship
  • Product Registration Management
  • Audit & Inspection Readiness
Requirements
  • Licensed pharmacist in the Philippines
  • Bachelor's degree in Pharmacy or a related field; Master's degree or regulatory certification preferred
  • At least 7-10 years of experience in Regulatory Affairs, with 3-5 years in a leadership role, preferably in the pharmaceutical industry
  • Comprehensive knowledge of FDA Philippines regulations and international guidelines
  • Proven track record of successful product registrations and interactions with regulatory agencies
Work Setup

Location: Paranaque

Set-up: Onsite 100%

Shift: Dayshift

The estimated annual salary for this position is PHP 2,500,000 - PHP 4,000,000, depending on qualifications and experience.



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