Regulatory Affairs, Biosimilars

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.

Educational Qualification

• Bachelors or Master’s Degree in Life Sciences, Pharmacy, Biotechnology, or related discipline.

Experience

• 3 to 6 years of experience in regulatory affairs, ideally with exposure to recombinant or biologic products.