Regulatory Affairs

Roles & Responsibilities:
• Handle preparation, review, and submission of API Drug Master Files (DMFs)
• Ensure compliance with ICH guidelines and global regulatory requirements
• Manage regulatory submissions for US FDA and other international markets
• Coordinate with cross-functional teams for data collection and documentation
• Support responses to regulatory queries, deficiencies, and post-submission activities
• Maintain regulatory documentation and ensure timely lifecycle management
• Monitor changes in global regulatory guidelines and implement updates

Qualification:
• Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm)

Experience:
• 2-3 years of experience
• Hands-on experience in API regulatory affairs with US FDA exposure preferred

Skills:
• Strong knowledge of API DMF preparation and submission
• Good understanding of ICH and global regulatory guidelines
• Experience in US FDA regulatory requirements
• Excellent documentation and coordination skills
• Ability to work in a fast-paced regulatory environment

About the Company:
Senores Pharmaceuticals Limited is a fast-growing Indian pharmaceutical company focused on the development and manufacturing of complex generics for regulated and emerging markets, including the US, EU, and ROW, with a strong commitment to global quality and compliance.