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Principal Consultant - Clinical

Principal Consultant - Clinical

PharmiwebDortmund, DE
Vor 5 Tagen
Stellenbeschreibung

Job Description

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.

    • LI-OG1