Regulatory Affairs Executive

Job Summary:

Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems.

Key Responsibilities:

• Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations.
• Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner.
• Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulations.
• Develop and submit variation packages for ongoing lifecycle management of approved products.
• Monitor and interpret changes in regulatory guidelines and approval processes worldwide.
• Conduct regulatory impact assessments for product or process changes.
• Support regulatory audits conducted by customers and Ministry of Health (MOH).
• Perform gap analysis and review clinical and CMC documentation to support regulatory submissions.

Skills & Competencies:

• Strong knowledge of global regulatory requirements and submission formats (FDA, EMA, ICH guidelines).
• Hands-on experience with preparation of IND, IMPD, CTD dossiers and regulatory documentation.
• Detail-oriented with excellent document management skills.
• Effective communication and coordination with cross-functional teams.
• Analytical skills to assess regulatory impacts and address compliance issues.
• Ability to work independently and manage multiple regulatory activities simultaneously.

Proficiency with regulatory submission tools and tracking systems.

Education Qualification: Master's Degree in Life Sciences, Pharmacy, Biotechnology, or related discipline.

Experience:

• 2 to 4 years of experience in regulatory affairs, ideally with exposure to recombinant or biologic products.