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:

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

Qualifications:

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

Benefits & Perks:

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

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