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Inviting applications for the role of Lea d Associate CMC Regulatory affairs – Management Trainee - English – On Site Munchen!

This project is staff support to a large client, filling in as a member for their team in-leu of their own.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 several regulatory functions specific to post-approval, lifecycle management capacities which includes -

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 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

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

Preferred Qualifications/ Skills

Relevant experience in CMC tasks and related aspects.

English + German language for CMC roles is something that client needs

What can we offer?

Attractive salary;

Stable job offers - employment contract

Work in a multicultural environment

Various trainings (initiating, soft skills)

Possibility of development

Benefits (transportation allowance, annual performance bonus, collective discount on your health insurance)