EU Regulatory Affairs Senior Manager - Rare Disease MAA

About the role

Join a global biotech company at a pivotal stage as a senior regulatory affairs contractor. You will support a high‑profile European Marketing Authorisation Application (MAA) for a rare disease therapy slated for submission in 2027, working closely with the EU Regulatory Lead and cross‑functional teams.

Key responsibilities

• Support delivery of a major EU MAA submission for a rare disease product.
• Coordinate submission activities across multiple functions and external partners.
• Review and interpret data with subject‑matter experts to prepare regulatory documentation.
• Assist the EU Regulatory Lead in executing regulatory strategy.
• Manage timelines and deliverables for internal and external stakeholders.
• Facilitate interactions with the European Medicines Agency (EMA) and ensure compliance with European regulatory requirements.
• Contribute to post‑approval regulatory activities for an already approved European product.

Required profile

• Proven experience preparing and filing EU Marketing Authorisation Applications.
• Background in rare disease or orphan drug development (preferred).
• Recent experience leading or owning MAA submissions.
• Strong knowledge of EMA processes and European regulatory frameworks.
• Ability to work independently in a hands‑on, delivery‑focused environment.
• Excellent written and verbal communication skills.

Required skills

What we offer

• 12‑month contract with a highly competitive daily rate.
• Opportunity to play a key role in a significant European MAA submission.
• Exposure to an innovative rare‑disease programme with meaningful patient impact.
• Visibility within a global regulatory team.