RESPONSIBILITIES:

Your duties as the Senior Manager of Regulatory Affairs with a focus on ATMP will be varied however the key duties and responsibilities are as follows:

  • Drive Regulatory strategy and operations in relation to product development and registration. 
  • Prepare high quality regulatory documentation including but not limited to CTA / IND / IMPD, Scientific Advice briefing packages, PRIME applications, PIP / PSP, MAA / BLA as well as responses to questions by relevant agencies.
  • Liaise with Regulatory agencies including the MHRA, EMA and FDA for EU and US markets where you will act as the point of contact for submission of relevant documentation
  • You will maintain and up to date knowledge of Global Regulatory requirements for ATMP products including Clinical and CMC aspects.
ROLE REQUIREMENTS:
  • Relevant degree in a life sciences discipline (i.e Biology, Biochemistry, Biotechnology, Pharmacology etc.) with hands on experience in a Regulatory Affairs environment within a Biotechnology / Biologics and / or Rare disease industry.
  • Proven industry experience in a Regulatory Affairs setting where you are contributing to the early development of products through to the preparation of CTA / IND strategy and submission to MAA / BLA filings to EU and US markets. 
  • Ability to plan and lead meetings with the FDA, EMA and European national regulatory authorities.