Global Regulatory Affairs Director — Drug Approvals & Strategy

Trades Workforce Solutions; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading pharmaceutical consultancy in Singapore is seeking an experienced regulatory affairs professional to manage the approval processes for new drugs and vaccines. The ideal candidate will have an advanced degree in Pharmacy or Biology and over 5 years of international regulatory affairs experience, with a proven track record of handling FDA and EMA approvals. This role involves developing submission documents and communication with regulatory agencies to ensure compliance and successful product registrations.

Qualifications

• Over 5 years of international regulatory affairs experience.
• Led at least two successful FDA or EMA drug approvals.
• Specialized in registering vaccines and biologics.

Responsibilities

• Manage the entire process of getting new drugs approved.
• Develop and evaluate submission documents.
• Communicate directly with regulatory agencies.
• Help develop registration plans for new markets.
• Work closely with different teams to ensure accuracy.

Skills

Advanced regulatory knowledge

Strong communication skills

Experience with electronic submission platforms

Team collaboration

Education

Master’s or PhD in Pharmacy, Biology, or related discipline

Tools

Veeva RIM

Job description

A leading pharmaceutical consultancy in Singapore is seeking an experienced regulatory affairs professional to manage the approval processes for new drugs and vaccines. The ideal candidate will have an advanced degree in Pharmacy or Biology and over 5 years of international regulatory affairs experience, with a proven track record of handling FDA and EMA approvals. This role involves developing submission documents and communication with regulatory agencies to ensure compliance and successful product registrations.