Regulatory Affairs Pharmacist

About the role

We are seeking a qualified Regulatory Affairs Pharmacist to lead the preparation and submission of regulatory documentation for our pharmaceutical and medical device portfolio. The role will ensure compliance with evolving regulations in the Philippines and other key markets while supporting product development and commercialization.

Key responsibilities

• Monitor and interpret changes in regulatory requirements and guidelines across pharmaceutical and medical device sectors.
• Prepare and submit marketing authorisation applications, clinical trial applications, and post‑approval variations.
• Interact with regulatory authorities to address queries and obtain product approvals.
• Provide regulatory guidance to R&D, manufacturing, and quality assurance teams.
• Maintain comprehensive records and databases tracking regulatory status of all products.
• Identify and mitigate regulatory risks affecting the business.
• Develop and implement regulatory strategies aligned with commercial objectives.

Required profile

• Pharmacy degree with a valid pharmacist registration.
• Minimum 5 years of experience in regulatory affairs within the pharmaceutical or medical device industry.
• In‑depth knowledge of regulatory requirements in the Philippines and other major markets.
• Strong written and verbal communication skills for effective stakeholder liaison.
• Excellent attention to detail and problem‑solving abilities.
• Ability to work independently and collaboratively in cross‑functional teams.

Required skills

• Proficiency with regulatory information management systems and databases.