Lead Associate CMC Regulatory affairs - Assistant Manager - English - On Site Munchen!

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 CMC Regulatory Affairs - Assistant Manager - English - On Site Munchen!

This project is staff support to a large client, filling in as a member for their team in lieu of their own. This program is intended to support the client in their requested requirement for regulatory submissions that may have an impact on registrations of small molecules, biologics, and combination products.

Responsibilities

Support through several regulatory functions specific to post-approval, lifecycle management capacities which include:

• First point of contact for CLIENT CMC contact for any data/information with respect to the project.
• Provide scientific inputs and actively involved in RA CMC strategic discussions.
• Lead cross-functional teams at CLIENT.
• Responsible for overall RA CMC activities.
• Continuously monitor, improve, and adjust the needs of the RA CMC team.
• Monitor assumptions, risks, and dependencies.
• Ensure timely tracking and reporting to CLIENT.
• Ongoing change management.
• Coordinate with RA CMC India resources on allocated tasks and ensure tasks are completed on time.
• Issue resolution; capturing feedback and complaints.
• Oversee planning of CMC regulatory changes and renewals.
• Provide regular progress reports and updates.

Manage and oversee regulatory post-approval Chemistry, Manufacturing and Controls (CMC) changes involving deliverables such as:

• Provide 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 Boehringer roles, processes, and systems.
• Provide input to management meetings for Head of Global CMC Regulatory Affairs, as needed.

Qualifications we seek in you!
Minimum Qualifications / Skills

• At least a bachelor's degree required in Pharmaceutical science, engineering, or related field (advanced degree preferred).

Preferred Qualifications/ Skills

• Relevant experience in CMC tasks and related aspects.