The Associate Director Regulatory Affairs EMEA role offers a fixed-term contract and the chance to make a real impact within a leading biopharmaceutical company. This is a full-time opportunity with no remote work available. While salary details are not explicitly mentioned, the position is known for a comprehensive package including generous holidays, stock plans, wellness support and professional development initiatives.

Day-to-Day Responsibilities & Job Details

As an Associate Director Regulatory Affairs EMEA, you will be responsible for developing and executing regulatory strategies for critical pharmaceutical products, mainly focused on rare diseases. Your core tasks include offering strategic input to development teams, reviewing and preparing regulatory documents, coordinating major applications and facilitating communications with regulatory agencies.

This position demands strong collaboration skills as you work with cross-functional teams, ensuring alignment of local EMEA regulatory requirements with global objectives. You will manage agency meetings, lead responses, and track commitments to guarantee compliance and timely approvals for projects in development and post-marketing phases.

Applicants should hold at least a Bachelor’s in life sciences, with an advanced degree strongly preferred. A minimum of 8 years’ regulatory experience and a deep understanding of EMEA and global regulatory frameworks are essential. Knowledge of the GCC region’s regulations and fluency in English, with Arabic as an asset, are required.

The schedule is based on a flex model, typically expecting onsite presence two to three days each week, offering a balance between collaboration and autonomy within the office environment.

Advantages of the Position

One of the most significant advantages is the opportunity to work on truly innovative, life-changing medicines for rare diseases, a field demanding both dedication and ingenuity. Ultragenyx is known for nurturing a culture that values growth, learning and individual wellbeing—promoting diversity and professional advancement throughout the organisation.

Employees benefit from an attractive package that spans vacation time, employee share schemes, wellness benefits and opportunities for further education. The role is also supported by flexible working days onsite and well-defined career development programmes.

Potential Drawbacks

This role requires a considerable level of expertise in regulatory affairs, making it less accessible to those with limited industry experience or knowledge outside the EMEA region. Additionally, it’s important to note that remote work is not an option, as regular onsite presence is expected.

Travel may be required on occasion, and high accountability on global teams could mean challenging timelines and the need for adaptability in a dynamic regulatory environment.

Verdict

Overall, the Associate Director Regulatory Affairs EMEA position is ideal for those with substantial experience in global regulatory affairs seeking purpose-driven work. If you’re looking to advance your career while contributing to rare disease treatments, this role stands out for its growth, benefits, and meaningful impact.