WHO YOU ARE:

You possess strong leadership and communication skills, enabling you to effectively guide and influence project teams. Your organizational skills are exceptional, allowing you to prioritize workloads and manage multiple tasks efficiently. You excel in building relationships and liaising with senior personnel across medical, scientific, and manufacturing domains. Your multicultural sensitivity and ability to navigate a multinational environment make you a valuable asset to our team. You thrive in collaborative settings, advocating for your department’s interests while promoting shared objectives.

REQUIRED SKILLS:

• Degree in Life Science or related discipline required; higher degree preferred (PharmD, MSc, PhD, MBA).
• Strong and proven experience within the pharmaceutical/biotechnology industry, including significant experience in Regulatory Affairs & Regulatory Affairs Strategy.
• Extensive experience with clinical and pre-clinical regulatory aspects of product development.
• Direct experience interfacing with relevant regulatory authorities (EMA and national Competent Authorities).
• Experience interpreting regulations, guidelines, and policy statements.
• Experience in preparing major regulatory submissions and supportive amendments or supplements.
• Late-stage development regulatory experience, including leading significant submissions (e.g., MAA).
• Strong interpersonal skills with a proven ability to engage effectively with senior personnel.
  Job Level: Management

ABOUT THIS ROLE:

As the EU Regulatory Strategy Lead, you will spearhead the development and execution of innovative regulatory strategies within our dynamic Global Regulatory Affairs team. In this pivotal role, you will lead the EU regulatory strategy for product development and approval, ensuring alignment with our overarching global business strategy. Your contributions will be vital in representing the company to EU and national regulatory authorities and in providing regulatory support across various departments and projects. You will play a key role in shaping regulatory approaches and initiatives, driving significant impact on organizational outcomes, and facilitating collaboration with cross-functional teams and external partners.
This is a hybrid role, requiring 50% office attendance per week.

WHAT YOU’LL DO:

• Direct EU regulatory strategies for assigned projects and programs, supporting the development of the Clinical Development Plan (CDP) and directing global lifecycle management.
• Identify and assess regulatory risks associated with product development, and define strategies to mitigate these risks.
• Set strategic direction and lead the EU regulatory submission process, including marketing applications and core briefing packages.
• Support the development of the Core Data Sheet and Summary of Product Characteristics (SmPC) and represent regulatory strategy at global labeling team meetings.
• Monitor and analyze regulatory agency activities and assess their impact on programs.
• Foster positive interactions with regulatory agencies and corporate partners.
• Lead and influence project teams and committees to achieve group goals.
• Represent the department in project teams, committees, and external meetings.