Lead Associate, Regulatory Affairs

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose the relentless pursuit of a world that works better for people we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

Inviting applications for the role of Lead Associate, Regulatory Affairs
This program is intended to support client in their requested requirement for regulatory submissions that may have impact on registrations of small molecules, biologics and combination products.

Responsibilities:
Support through a number of regulatory functions specific to post-approval, lifecycle management capacities which includes

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:
Provide of regulatory evaluation of change control (affected countries, data/documentation requirements per country, change category per country and regulatory procedure per country) and regulatory strategy
Provide 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
Manage and oversee support for renewals and post approval CMC commitment involving deliverables such as:
Provide 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

Qualifications we seek in you
Minimum Qualifications / Skills

Atleast Bachelors degree required in for Pharmaceutical: science, engineering, or related field (advanced degree preferred).

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a starter kit, paying to apply, or purchasing equipment or training.