EU Regulatory Affairs Snr Manager - Rare Disease MAA

Your new company
A 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 role

We 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 product
• Coordinating submission activities across multiple functions
• Reviewing and interpreting data with SMEs to support regulatory documentation
• Working closely with the EU Regulatory Lead on regulatory strategy execution
• Managing deliverables and timelines across internal teams and external partners
• Supporting interactions with EMA and European regulatory requirements
• Contributing to post-approval regulatory activities on an approved programme
• Collaborating within a global regulatory team

What you''ll need to succeed

• Proven experience preparing and filing EU Marketing Authorisation Applications (MAAs)
• Rare disease experience
• Orphan drug experience preferred
• Recent experience owning or leading MAA submissions
• Strong knowledge of EMA processes and European regulatory requirements
• Paediatric development experience advantageous
• Experience working with external partners and collaborations
• Strong written and verbal communication skills
• Ability to work independently in a hands-on delivery-focused role
• Collaborative approach with experience working across global, cross-functional teams

What you''ll get in return

• 12-month contract
• Opportunity to play a key role in a significant European MAA submission planned for 2027
• Exposure to an innovative rare disease programme with meaningful patient impact
• Highly visible role within a global regulatory team
• Highly competitive rate

What you need to do now

If you''re interested in this role, click ''apply now'' to forward an up-to-date copy of your CV, or call us now.If this job isn''t quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.