The EU and Global Regulatory Lead will be responsible for developing and delivering innovative, regulatory strategies for product development, approval and post-approval activities, in alignment with the EU and global business strategy. The principal responsibility of the EU/GRL will be to develop and to lead EU and Global regulatory planning and to execute regulatory interactions for an established therapy in MS.
The role reports in through the EU Regulatory team with a dotted line to the Global Regulatory team.

Accountabilities:

• Responsible for leading a comprehensive and strategic approach to developing and executing integrated regulatory strategies that account for the complex interplay between major Regulatory Authorities (including EU, US, Japan and China).
• Represent the company with Regulatory Authorities and corporate partners. Provide regulatory support for various departments, projects, and teams/committees.
• Set strategic direction and lead EU and global regulatory submission process with submission teams, including marketing applications, post-approval applications and core briefing packages.
• Responsible for line management for Regulatory Managers. Guide direct reports in carrying out responsibilities and career development.
• Develop and maintain the Core Data Sheet, EU product information and lead labeling team meetings.
• Advise on global CTA submission strategy, working closely with a CTA team.
• Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development. Provide input to Regulatory Senior Management teams.
• Identify and assess regulatory risks associated with product development, including an active lifecycle plan. Define strategies to mitigate risks.
• Provide regulatory guidance to company personnel throughout the research and development process and post-approval stage.

Qualifications

• Degree in Life Science or related discipline required. Higher degree preferred (PharmD, MSc, PhD, MBA).
• Strong experience within the Pharmaceutical/Biotechnology industry with technical management experience. Solid experience required in Regulatory Affairs (Strategy).
• Expert knowledge with respect to the respective regulatory landscapes in the EU, US and Japan.
• Direct experience in interfacing with relevant regulatory authorities (FDA, EMA, and PMDA).
• Experience in interpretation of regulations, guidelines and policy statements.
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
• Supervisory/mentoring experience, including ability to guide, train, supervise and prioritise workload of direct reports.

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.