Senior Manager, Regulatory Affairs CMC (Cambridge)

Job title: Senior Regulatory Affairs Manager CMC

A growing pharmaceutical business in London are seeking a Senior Regulatory Affairs Manager CMC to join their team. The role will be responsible for the development, execution and tracking of regulatory CMC activities, specifically the preparation of briefing packages for Scientific Advice of Biosimilar products.

Responsibilities:

• Participate during the interactions with Competent Authorities (EMA, National EU Authorities, Health Canada, TGA and others). Address issues/requests by the Agency during MAA.
• Preparation of regulatory roadmaps and gap analysis for the development of biosimilars up to approval.
• Provide support and guidance to the BD&L Team when evaluating new projects and M&A by conducting dossier due diligence.
• Report on regulatory progress and issues for new products or LCM activities at all project team and Project Review Meetings, and to Senior Management as required.

Requirements:

• Experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry
• Relevant and current experience in submissions/managing of National and European MAA and support product launches.
• Working knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations
• Experience interacting with EU regulatory authorities – Scientific advice meetings/ Pre-submission meetings.
• Degree in Life Sciences would be beneficial

Salary and benefits:

A highly competitive salary and wider benefits scheme is on offer

To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk