EU Regulatory Affairs Snr Manager - Rare Disease MAA

Your new companyA global biotech company focused on developing transformative therapies for patients living with rare diseases. With a major European submission on the horizon, this is an opportunity to join at a critical stage and play a hands-on role in bringing an important treatment closer to patients.Your new roleWe are looking for an experienced Regulatory Affairs contractor to support a high-profile European Marketing Authorisation Application (MAA) planned for submission in 2027.This role supports the EU Regulatory Lead and taking ownership of key MAA activities. The dossier modules are being prepared, and you''ll work cross-functionally to drive the submission forward, coordinate stakeholders, interpret data with SMEs and support interactions with European regulators.Alongside the MAA programme, you could also support post-approval regulatory activities for another recently approved product in Europe.Key responsibilities include:Supporting delivery of a major EU MAA submission for a rare disease productCoordinating submission activities across multiple functionsReviewing and interpreting data with SMEs to support regulatory documentationWorking closely with the EU Regulatory Lead on regulatory strategy executionManaging deliverables and timelines across internal teams and external partnersSupporting interactions with EMA and European regulatory requirementsContributing to post-approval regulatory activities on an approved programmeCollaborating within a global ..... full job details .....