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:

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.