Global Regulatory Affairs Manager – Biopharma

Apsida are currently recruiting on behalf of a well-established, Global pharmaceutical company who are entering an exciting period with further expansion of their rare disease portfolio. We are searching for a Global Regulatory Affairs Manager who will be managing and implementing EU/US/ROW Regulatory strategies for a recently in licensed product. This organisation has gone from strength to strength and boast a well performing portfolio of products across multiple therapeutic areas, including rare diseases. Responsibilities: This role will take the lead on the design and execution of certain sections of regulatory submissions such as variations, renewals and CTA applications Manage post-approval submissions in approved territories (EU/US) as well as managing the submission process in ROW countries (in conjunction with CROs/Partners) Manage the submission of ongoing and new marketing authorisation applications in rest of world countries For any new indications in development to be primarily involved in the preparation and submission support for clinical trial, applications, scientific advice procedures, orphan designation requests and Paediatric Investigation Plans (PIPs) Requirements: Life science related degree Minimum of 5 years Regulatory Affairs experience, with working knowledge in EU and/or International markets Experience of regulatory requirements for registering a new drug product in ROW countries Previous experience in using the centralised procedure in the EU would be an advantage If you are interested in learning more, please reach out to Ethan Cortese at Apsida Life Science: www.apsida.co.uk 44 (0) 203 854 4606 Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK) & Boston (USA) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.