CMC Regulatory Affairs Manager

Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Manager to join their team in Cambridge.

This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science.

Key Responsibilities

• A key role in the execution of CMC regulatory strategies working on multiple cross functional projects
• Oversee all regulatory submissions as well as reviewing and altering dossiers as necessary ensuring that these are compliant
• Liaise with and build good relationships with affiliates, sites, regulatory agencies and other internal and external stakeholders
• Maintain an active awareness of EU and EEMEa Regulatory legislation

Requirements

• Previous experience in UK EU regional Regulatory Affairs and Compliance particularly within the pharmaceutical industry
• Experience in CMC and emerging markets, ideally Russia/Balkans
• Full regulatory lifecycle process experience highly advantageous
• Experience of EU/Swiss variations
• Good understanding of regulatory procedures such as CTAS, marketing authorisations and post approval
• Strong communication and stakeholder engagement skills
• Proactive manner

Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.