At a Glance
- Tasks: Support a major EU submission for a rare disease treatment and coordinate cross-functional activities.
- Company: Global biotech company dedicated to transformative therapies for rare diseases.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Dynamic role with the chance to influence important regulatory processes.
- Why this job: Join at a critical stage and make a real difference in patients' lives.
- Qualifications: Experience in Regulatory Affairs and strong collaboration skills required.
The predicted salary is between 60000 - 80000 £ per year.
Your new company is 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 involves supporting a high-profile European Marketing Authorisation Application (MAA) planned for submission in 2027. This role supports the EU Regulatory Lead and takes ownership of key MAA activities. The dossier modules are being prepared, and you will 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
EU Regulatory Affairs Snr Manager - Rare Disease MAA employer: Hays Life Sciences
As a leading global biotech company, we pride ourselves on fostering a collaborative and innovative work environment that empowers our employees to make a real difference in the lives of patients with rare diseases. Our commitment to employee growth is reflected in our comprehensive training programmes and opportunities for career advancement, all while working in a dynamic European setting that is at the forefront of regulatory affairs. Join us to be part of a mission-driven team where your expertise will directly contribute to transformative therapies and impactful patient outcomes.
