Principal Consultant - Clinical

Clinical/Regulatory Consultant

Location: Munich, Germany - Hybrid

The Company is a dynamic organization at the forefront of innovative drug development. We offer a unique opportunity for a highly motivated and experienced Clinical/Regulatory Consultant to join our cross-functional development teams.

About the Role

In this matrix-structured role, you will provide strategic guidance and expertise to development teams working on a variety of cutting-edge projects, including small molecules, biologicals, and ATMPs. You will be involved in all stages of development, from pre-clinical research to regulatory submissions (MAA, NDA/BLA).

Key Responsibilities:

1. Offer strategic regulatory advice and support to project teams.
2. Oversee all clinical development aspects within project teams.
3. Develop and execute a comprehensive global regulatory plan.
4. Lead the development and implementation of the global agency interaction strategy.

Qualifications:

1. Advanced degree in life sciences, medicine, or veterinary medicine.
2. Minimum of 10 years of experience in pharmaceutical development.
3. Proven track record in strategic clinical development and regulatory affairs (experience in people management is not sufficient).
4. Experience working across different pharmaceutical companies and/or regulatory authorities (a plus).
5. Excellent communication and interpersonal skills, with the ability to explain complex development scenarios.
6. Strategic thinking, solution-oriented approach, and strong problem-solving skills.
7. Ability to work independently, manage multiple tasks under pressure, and prioritize effectively.
8. Experience with EU and US regulatory procedures is preferred.

Benefits & Perks:

1. Competitive salary, with no pre-set cap (negotiated based on experience).
2. Comprehensive relocation package, including assistance with finding accommodation, schooling, and navigating bureaucratic processes.
3. Opportunity for continuous professional development through exposure to diverse, cutting-edge projects, not through hierarchical advancement.
4. Non-client facing role, allowing you to focus on your expertise.