Job Scope: What is this job’s focus?

The Associate Director, EU CTR Strategy & Operations supports the Head of EU CTR in providing strategic, operational, and people leadership for the EU CTR Submission team. The role is accountable for the overall operational performance of the team, including line management of the EU CTR Submission organization, operational delivery, strategic planning, and continuous improvement of EU Clinical Trials Regulation (EU CTR) processes.

Acting as the operational deputy to the Head of EU CTR, the Associate Director ensures high-quality, compliant, inspection-ready, and efficient execution of EU CTR submissions and lifecycle management activities while driving a harmonized and scalable operating model across all EU Member States.

Strategic Leadership & Operational Oversight

• Support the Head of EU CTR in defining and executing the EU CTR operational strategy and long-term operating model.

• Lead the operational execution of the EU CTR submission organization, ensuring delivery of compliant, high-quality, and timely CTIS submissions and lifecycle activities.

• Translate strategic objectives into operational priorities, resource plans, and organizational capabilities.

• Drive organizational effectiveness and scalability to support future business growth.

Organizational Leadership & Line Management

• Provide direct line management for the EU CTR Submission team, including Senior Leads, Leads, and Specialists.

• oversee a high- performing, engaged, and accountable submission team through coaching, mentoring, and performance management.

• Establish performance objectives, development plans, and succession strategies.

• Lead workforce planning, resource allocation, and capacity management.

• Foster a culture of collaboration, accountability, continuous learning, and operational excellence.

Operational Excellence & Governance

• Sponsor and oversee the EU CTR operating model, including governance frameworks, KPIs, operational controls, and performance dashboards.

• Ensure alignment of EU CTR operational processes with corporate regulatory strategies and global process standards.

• Provide executive oversight of process control reviews, quality metrics, inspection readiness, and operational risk management.

• Ensure continuous improvement initiatives are implemented through the Lead, Strategy & Operations Excellence.

Regulatory Compliance & Inspection Readiness

• Ensure compliance with EU CTR, CTIS requirements, EMA guidance, and internal quality standards.

• Provide executive oversight for inspection readiness, internal audits, and regulatory inspections.

• Oversee CAPA implementation and operational risk mitigation.

• Act as senior escalation point for complex regulatory and operational issues.

Capability Development & Organizational Growth

• Develop organizational capability through leadership development, succession planning, and talent management.

• Sponsor the EU CTR learning strategy and capability framework.

• Mentor Senior Leads and Leads to build future leadership capability.

• Promote a culture of continuous improvement and knowledge sharing.

Cross-functional Leadership

• Lead strategic collaboration with Regulatory Affairs, Clinical Development, Clinical Operations and Country and sites Operations

• Represent EU CTR Operations in senior governance forums.

• Build partnerships with regulatory authorities, CROs, and industry groups.

Essential Skills and Qualifications Required:

• Advanced degree (Pharmacy, Life Sciences, or related discipline) or equivalent professional experience.
• Minimum 12 years of experience in clinical or regulatory operations including within the EU region.
• Demonstrated people leadership and talent development experience.
• Strong background in process excellence, continuous improvement, and training program development.
• Demonstrated leadership and influence in a complex, matrix environment.
• Strong knowledge of the EU regulatory landscape, clinical trial operations, and regulatory submissions.
• Excellent strategic thinking, problem-solving, and project management skills.
• Superior interpersonal, communication, and organizational abilities

Education and Experience Requirements for Job:

Education

Advanced degree (Pharmacy, Life Sciences, or related discipline) or equivalent professional experience.

Experience

Extensive Minimum 12 years of experience in clinical or regulatory operations within the EU region, learning and capability building, process control and change management.

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.