Regulatory Procedural Management and Clinical Trial Lead (m / f / x), Regulatory Affairs Europe

Daiichi Sankyo Europe; München; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Senior Director for Regulatory Procedural Management and Clinical Trial Lead. This pivotal role focuses on product development and regulatory lifecycle management across Europe and AMELA. You will lead a dynamic team, ensuring compliance and driving strategic initiatives to enhance organizational processes. With a commitment to innovation and patient care, this role offers the opportunity to make a significant impact in the pharmaceutical landscape. If you are a proactive leader with extensive regulatory experience, we invite you to join a culture that values respect, learning, and diversity.

Leistungen

Health Insurance

Professional Development Opportunities

Flexible Working Hours

Employee Assistance Program

Diversity and Inclusion Initiatives

Qualifikationen

• 10+ years in the pharmaceutical industry focusing on regulatory activities.
• Experience in clinical development and engaging with regulatory authorities.

Aufgaben

• Lead Regulatory Procedural Management and Clinical Trial Office.
• Ensure compliance for clinical trials in the EU and AMELA.

Kenntnisse

Regulatory Affairs

Project Management

Leadership

Communication Skills

Interpersonal Skills

Knowledge of Regulations

Ausbildung

Bachelor in Pharmacy, Medicine, Life or Natural Sciences

PhD

TOPRA Diploma or Master in Regulatory Affairs

Tools

MS Office

Document Management Systems

Databases

Jobbeschreibung

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: our Specialty Business aims to protect people from cardiovascular disease, the leading cause of death in Europe, and to help patients suffering from it enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, with affiliates in 13 European countries and Canada.

We are seeking highly qualified candidates to fill the position:

Regulatory Procedural Management and Clinical Trial Lead (m/f/x), Regulatory Affairs Europe

The Position:

This Senior Director role emphasizes product development and regulatory lifecycle management in Europe and AMELA (Australia, Middle East, Eastern Europe, Latin America, Africa). It provides regulatory leadership, guidance, project management, and procedural strategy to assigned projects, ensuring they are scientifically sound, commercially viable, and compliant with regulatory standards.

Responsibilities include leading EU & AMELA Regulatory Procedural Management and Clinical Trial Office, providing oversight of regulatory procedures, clinical trial applications, and compliance.

The role involves representing RA and Daiichi Sankyo Europe in interactions with project teams, affiliates, license partners, authorities, and industry associations related to clinical trials and regulatory procedures. It also includes leading or supporting projects to enhance organizational processes and adapt to regulatory changes.

Key duties involve:

• Leading the Regulatory Procedural & Project Management team in the EU & AMELA, acting as a link between Regulatory Strategists and other disciplines within RA and R&D.
• Guiding the EU & AMELA Regulatory Procedure & Management team and providing operational strategy for development projects and marketed products.
• Supporting the Clinical Trial Office Team to ensure smooth regulatory applications and compliance for clinical trials in the EU.
• Leading initiatives to improve RA processes and functionality.
• Mentoring internal and external reports, managing priorities, and ensuring effective team performance.

Education & Professional Experience:

• Bachelor, Master, State Examination, or Diploma in pharmacy, medicine, life or natural sciences; PhD preferred.
• Post-doctorate or professional experience in pre-clinical research or clinical development; TOPRA diploma or Master in Regulatory Affairs is a plus.
• Deep knowledge of global and European laws, regulations, and guidelines for medicinal product marketing authorization, including experience with China.
• At least 10 years in the pharmaceutical industry, CRO, or regulatory authority, focusing on regulatory activities, submissions, and amendments, including pediatric development experience.
• Experience working in a global and European regulatory environment and engaging with authorities.
• Strong interpersonal, leadership, and communication skills, with the ability to work effectively across functions in a multinational setting. Well-organized, detail-oriented, self-motivated, and ethical.
• Ability to foster positive interactions with regulatory agencies and partners, leading project teams and committees effectively.
• Proficiency in MS Office, document management systems, databases, and excellent English communication skills; German and a third language preferred.

Why work with us?

Working at Daiichi Sankyo offers the chance to make a meaningful difference in patients’ lives. We foster a culture of respect, learning, inclusion, and diversity, encouraging growth, innovation, and idea contribution. If you are proactive and passionate about patient needs, we look forward to your application.

Location: Munich, Germany