Regulatory Manager

Regulatory Manager focuses on this new position will take a business lead for all regulatory activities to support both clinical and commercial processes.

What the role involves

• This new position will take a business lead for all regulatory activities to support both clinical and commercial processes.
• Due to an increasing and evolving product portfolio, this new function will take a direct responsibility in liaising with the regulatory bodies and work with corporate QA.
• Lead, manager, specialist, sterile, biological, vaccine, atmp, cell, gene.

Skills and requirements

• Established regulatory experience (minimum 5 years) within pharmaceutical sterile/biological products.
• IMP experience is essential.

Candidate fit

• Track record in leading communication with regulatory bodies.

Additional role context

• We are supporting a long-standing client with further expansion of their quality team across the UK.
• Work closely with several manufacturing facilities across the UK and will be the internal SME on all things regulatory.
• The split of the role will be around 70% regulatory focused but 30% of your time will still be attributed towards quality activities.