Regulatory Affairs -Specialist ATMP

I am currently searching for an experienced Biologics Regulatory Affairs Manager. You will be working for an organisation that pride themselves on hands on training and development.. If you are passionate about cell and gene therapies and working with companies who develop cutting edge technologies to make a positive impact on the patients life then this is the role for you.

What will be expected of you as the new Regulatory Affairs Specialist? You will be expected to provide operational and strategic regulatory advice to clients in a consultative manor. Provide support with gap analyses, advice of filing routes, orphan drug designation, regulatory authority interactions and Regenerative Medicines Advanced Therapy Designation. You will also be preparing regulatory submission documents such as scientific advice briefing documents, clinical trial applications, investigational new drug applications and marketing authorisation applications.

What necessary experience must you have?

• At least 4 years experience within Regulatory Affairs
• Exposure with ATMP's
• Experience with the EMA and FDA
• Have strong communication, with an aptitude for providing great service to clients or customers
•  A strong knowledge and understanding of the ever evolving regulatory guidelines and changes to legislation

What about the organisation?

This is a fast-paced growing consultancy which specialise in developing groundbreaking ATMP's, Biological and small molecule therapies for a range of conditions many being rare disease and oncology therapy areas. They have an international client base comprising of early life science organisations as well medical device companies. They have worked to create a friendly collaborative environment for their team, where they utilise individuals skills to work in the most effective and efficient manor.

Does this sound like the next step for you? If so please get in touch on hwright@barringtonjames.com or apply now.