Regulatory Affairs Pharmacist

5 days ago

Dasmariñas, Philippines Sydenham Laboratories Inc Full time
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

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