Regulatory Affairs Pharmacist

What you'll be doing

Staying up-to-date with changing regulatory requirements and guidelines in the pharmaceutical and medical device industries

Preparing and submitting regulatory documentation such as marketing authorisation applications, clinical trial applications, and post-approval variations

Liaising with regulatory authorities to address queries and secure approvals for our products

Providing regulatory guidance and support to the research and development, manufacturing, and quality assurance teams

Maintaining comprehensive records and databases to track the regulatory status of our product portfolio

Identifying and mitigating potential regulatory risks to the business

Contributing to the development and implementation of regulatory strategies aligned with the company's commercial objectives

What we're looking for

Pharmacy degree and valid registration as a pharmacist

Minimum 5 years' experience in a regulatory affairs role within the pharmaceutical or medical device industry

In-depth knowledge of regulatory requirements and guidelines in the Philippines and other key markets

Excellent written and verbal communication skills, with the ability to liaise effectively with both internal and external stakeholders

Strong attention to detail and problem-solving skills

Ability to work independently and as part of a cross-functional team

Proficiency in using regulatory information management systems and databases