Regulatory Affairs Manager - new job in Runcorn, UK

SRG are currently looking for a Regulatory Affairs Manager to join a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 6 Month contract to be based at their office in Runcorn.The Role:Provide Technical Leadership and Management of Regulatory Teams through coordination of resources across new product submission, site maintenance and regulatory compliance at the Runcorn facility. Key Responsibilities:

• Project and Resource Management to provide technical expertise to plan, resource and coordinate the delivery of projects to support the achievement of product launches and variations.
• Coordination of meetings with Global and Regional teams.
• Identification of issues and factors that may implicate a regulatory strategy or activity.
• Responsible for the strategy and execution of the site-specific aspects of the preparation of CMC amendments and post market activity.

Skills/Experience Required:

• Good understanding of the drug product life-cycle from development to product launch.
• Good coaching skills to lead and mentor development of the regulatory teams.
• Good project management skills with the ability to oversee multiple projects simultaneously.
• Responsible for the strategy and execution of site specific changes in the preparation of CMC amendments and post market supplements.
• Strategic thinking as well as hands-on experience with different registration procedures including the US, EU and IMT regions.

Education/Experience

• Minimum Qualification - degree in Chemistry, Life Sciences or related.
• Extensive regulatory knowledge in pharma environments in the US,EU and IMT markets.
• Knowledge of cGMP regulatory requirements of pharma products/ development processes in drug product steriles.
• Strong Project Management skills.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.