Regulatory Affairs Manager

About the role

The Regulatory Affairs Manager will lead the regulatory team to ensure all pharmaceutical products meet the requirements of the Philippines FDA and international standards. This senior position partners with Business Development and Marketing to embed compliance throughout product development and market launch.

Key responsibilities

• Ensure all company products and activities comply with FDA Philippines regulations and global standards.
• Oversee preparation, submission, and approval of product registrations, renewals, and variations.
• Serve as the primary liaison with FDA Philippines and other regulatory authorities.
• Collaborate with Business Development and Marketing to meet regulatory requirements at every development stage.
• Maintain accurate regulatory documentation and provide regular compliance reports to senior management.
• Lead, mentor, and develop the Regulatory Affairs team to sustain high performance.
• Identify, assess, and mitigate regulatory risks to protect market access.
• Prepare the organization for audits and inspections.

Required profile

• Licensed pharmacist in the Philippines.
• Bachelor’s degree in Pharmacy or related field; Master’s degree or regulatory certification preferred.
• 7‑10 years of regulatory affairs experience, with 3‑5 years in a leadership role within the pharmaceutical industry.
• Deep knowledge of FDA Philippines regulations and international guidelines.
• Proven record of successful product registrations and effective agency interactions.
• Excellent communication, negotiation, leadership, project‑management, and problem‑solving abilities.

Required skills