Director, Regulatory Affairs

Director, Regulatory Affairs - Europe & UK

JDRF

Remote (Europe)

BROAD FUNCTION AND SCOPE OF THE POSITION:

• Lead and develop JDRF strategy to accelerate research and regulatory approval for T1D drugs, biologics, and devices in Europe and the UK
• Coordinate and collaborate with Senior Director, Regulatory Affairs to ensure alignment with overall JDRF regulatory strategy.

SPECIFIC RESPONSIBILITIES:

• Develop and implement JDRF strategies to accelerate research and regulatory approvals for T1D drugs, biologics, and devices in Europe and UK, such as cell therapies, disease modifying immune therapies, and therapies to improve glucose control and complications associated with type 1 diabetes.
• Develop and maintain effective relationships with leadership and staff at regulatory agencies overseeing T1D therapies in Europe and UK, such as the EU European Medicines Agency (EMA) and the Medicines and UK Healthcare products Regulatory Agency (MHRA).
• Engage with industry partners regarding regulatory strategy, approach and processes in Europe and UK.
• Provide regulatory support for JDRF grants to ensure that investigators in Europe and UK are able to obtain the necessary approvals needed to conduct studies.
• Track, assess and evaluate legislative and regulatory policy proposals in Europe and UK to ensure JDRF priorities are advanced.
• Report on progress and advise JDRF leadership and allies on regulatory issues in Europe and UK as needed.
• Identify needs for outside regulatory advisors and oversee work.
• Engage and collaborate with JDRF Affiliates in Europe, namely JDRF UK and JDRF Netherlands, on overall strategy, common regulatory policy priorities, and approach to key decisionmakers.
• Collaborate closely with members of the JDRF Research and Advocacy teams.
• Perform other duties as assigned by his/her immediate supervisor.

EDUCATION:

• Advanced scientific, legal, or business degree preferred.

YEARS OF EXPERIENCE:

• 7+ years of related experience required.

KNOWLEDGE:

• Extensive knowledge of European regulatory laws, guidelines, processes, and officials. Knowledge of other regulatory agencies a plus.

OTHER REQUIREMENTS:

• Proven track record of success in regulatory policy and affairs for complicated medical therapies.
• Experience successfully managing projects and initiatives in a coordinated strategy.
• Self-starter that requires little supervision and can work and make judgments independently.
• Ability to effectively multi-task, establish priorities, and work in a fast-paced environment.
• Excellent written, oral, and communication skills.
• Travel within Europe and to the U.S. (approximately 10%).