CMC Consultant – Regulatory affairs

Smart Edge’s Client is looking for an individual to help with their CMC Consultant – Regulatory affairs @ Remote (UK /EU any where)

Key area:

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 any data / information with respect to the project.
• Provide scientific inputs and actively involved in strategic discussions
• Leads cross functional teams at CLIENT,
• Responsible for overall CMC activities.
• Continuously monitor, improve, and adjust the needs of CMC team
• Monitor assumptions, risks and dependencies
• Ensure timely tracking and reporting to client;
• On-going change management;
• Coordinate with India resources on allocated tasks and ensure tasks are completed on time;
• Issue resolution; Capturing feedback and complaints

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

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

If this sounds like a role you would be interested in or if you know someone in this field.

Connect with me or email me at nagamani.y@smartedgesolutions.co.uk

Alternatively, you can call me on Tel: +44(0)203 500 2108.