Head of Regulatory Affairs in ATMP - UK - Change lives

Head of Regulatory Affairs in ATMP - UK - Change lives

If you want to save people's lives, it can be difficult to do it if you don't have your hands on the product. However, as the head of Regulatory Affairs, you will make sure that the cell technologies are saving those who need them the most!

My client, a top player in the AT MP is looking for a Head of Regulatory Affairs in order to ensure that their products continue to meet the highest standards.

The British company is in the process of massive and ambitious expansion, so you would often travel to the different subsidiaries across Europe - Sevilla, Paris and those that are yet to come. Thus, you will find yourself interacting with many different people and cultures which will make your work routine much more interesting!

Furthermore, its nano-particles and cell technology demonstrates potential for the treatment of a broad range of serious diseases across oncology, cardiovascular, neurological and ocular diseases, and genetic disorders. If you are fascinated by STEM cells and microbiology, you will not even feel that you are at work.

At the same time, you will become the board member so bring all your ideas with you.
Your voice will matter!

Daily, you will be based in London, one of the most architecturally powerful cities in the world, but you will leave the walls of your office quite often.

You are a perfect candidate for the position if you:

• Have minimum 5 years of experience in global regulatory affairs (director / associate director level)
• Have BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field.
• Have a post-graduate qualification in relevant discipline, such as regulatory, Quality control and assurance, drug development, biotechnology, or equivalent regulatory experience.
• Have minimum of 5 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent.
• Have experience in biologics.
• Have previous cell and/or gene therapy experience (strongly preferred).
• Have demonstrable experience in the delivery of regulatory CMC strategy and documentation during drug development and/or product maintenance.
• Have experience with EMA, FDA and other regulatory agencies, especially dealing with MAA / BLA submission and pre-IND / CHMP SA advice meetings regarding ATMPs.
• Are fluent in English.
• Have experience supporting business development activities and people management.
• Are willing to travel on a regular basis (e.g., subsidiaries).

Are you not convinced by the position or simply looking for something else? Check out what else do we have to offer at https://nonstopconsulting.com/vacancies/