Regulatory Affairs Officer - ANDA & CMC

Centaur Pharmaceuticals is seeking a detail-oriented Regulatory Affairs Officer with experience in the US market. The role involves managing CMC documentation and ensuring FDA compliance for successful ANDA filings.

• Author and compile CMC documentation for ANDA filings and post-approval submissions.
• Coordinate with internal stakeholders regularly to source required documents within project timelines.
• Review technical documents against FDA guidances to assure full regulatory compliance.
• Maintain up-to-date knowledge regarding international regulatory guidelines and industry changes.
• Utilize eCTD software for the preparation and submission of regulatory packages.

• Qualification: M.Pharm, B.Pharm, or M.Sc.
• 2-3 years of proven experience in Regulatory Affairs focusing on the US market.
• Hands-on experience with eCTD software and pharmaceutical submission formats.
• Strong understanding of FDA guidance and CMC documentation standards.
• Excellent coordination and communication skills for stakeholder management.

• Opportunity to work with a leading pharmaceutical organization.
• Professional growth in the international regulatory affairs domain.
• Exposure to US market compliance and complex ANDA projects.
• Collaborative and professional work environment.