Lead Associate CMC Regulatory affairs – Assistant Manager – English – On Site Munchen!
GenpactMunich, GermanyGenpact (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 Lea d 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-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 -
- 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
- Leads cross functional teams at CLIENT,
- Responsible for overall RA CMC activities.
- Continuously monitor, improve, and adjust the needs of RA CMC team
- Monitor assumptions, risks and dependencies
- Ensure timely tracking and reporting to CLIENT;
- On-going 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 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 :
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
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.