Head of Regulatory Affairs

My client is an exciting Biotech operation who are developing first in class therapies to truly change patients lives. They are seeking an experienced Regulatory Affairs leader to take control of every aspect of the regulatory function.

As the Head of Regulatory Affairs you will work with the internal and external stakeholders to define and execute Regulatory strategy. You will be reporting directly to the Board of Directors and will lead meetings aross departments and with regulatory agencies.

The Head of Regulatory Affairs will have:

• Experience managing, developing and coaching teams
• Be degree educated in a relevant life science discipline (Advanced Degree preferential)
• A technical understanding of the chemical makeup of Advanced therapies and biologics
• 12+ years within Regualtory Affairs
• Experience working with early stage development
• Recent hands-on experience writing and submitted regulatory documentation
• Extensive understanding of Global Regulatory Affairs guidelines, most specifically EMA & FDA
• Be an organised, detailed orientated person
• Not only be able to make key technical decision but also business decisions

What is in it for you?

• A competative salary & benefits package
• Contribute to work that makes an impact on patient lives
• Work from home flexibility
• Stocks & Shares scheme

If you are looking for a challenge that will see your ability as a Regulatory Affairs expert develop then get in touch now.