Lead Consultant - Regulatory Affairs

Genpact is seeking a Lead Consultant - Regulatory Affairs to support a client in their regulatory submissions. The role involves providing scientific inputs, monitoring assumptions, and managing regulatory post-approval Chemistry, Manufacturing and Controls (CMC) changes. The ideal candidate has experience working in major regulated markets, such as the EU, US, Japan, and China.

Requirements

• Provide scientific inputs and actively involved in RA CMC strategic discussions
• Monitor assumptions, risks and dependencies
• Manage and oversee regulatory post approval Chemistry, Manufacturing and Controls (CMC) changes involving deliverables such as: regulatory evaluation of change control, tracking list and review documentation, dispatch final documentation package to Local Regulatory Affairs (LRA) in affected countries, monitor timely submission and approval in affected countries, manage and coordinate responses to health authority questions
• Overall planning of all CMC regulatory changes per product together with relevant interfaces
• Represent G CMC RA in cross-functional teams
• Experience working for major regulated markets – EU (different types of variations, work sharing/ super grouping), US, Japan, China
• Manage and oversee support for renewals and post approval CMC commitment involving deliverables such as: regulatory requirements and regulatory strategy to relevant interfaces, review documentation, dispatch final documentation package to Regional Regulatory Lead (RRL) for further distribution to LRAs, manage and coordinate responses to health authority questions, overall planning of all renewals per product together with relevant interfaces
• Represent G CMC RA in cross-functional teams
• CMC management: Authoring of Dossier sections – Module 2 and Module 3 – DS and DP according to the relevant regulatory requirements and GMP rules.
• Compilation of CMC documents for MAA, renewals, variations, commitments, Response to health authority queries
• Interaction and cooperation with experts from the relevant departments and CMOs (contract manufacturers and contract laboratories), also in non-European countries, to compile the information and data required for Module 3.2.P.
• Interaction with competent authorities in the context of ASMF/DMF and CEP activities.
• General tasks: Support and coordination of audit and inspection related activities, Maintain up-to-date knowledge of regulatory requirements and guidelines, Provide regular progress reports and updates, Acting and living in client processes, and systems

Benefits

• Competitive salary
• Comprehensive benefits package
• Opportunities for career growth and professional development
• Collaborative and dynamic work environment
• Recognition and rewards for outstanding performance