Senior Regulatory Affairs Manager – (Biotech)

  • Regulatory Affairs
  • Germany

Job description:

Location: Germany (Munich, Hybrid) | Job Ref: AXRAM007

Overview:

Our client, a clinical-stage biotech focused on oncology and CNS disorders is seeking a Senior Regulatory Affairs Manager to lead global submissions and contribute to early development strategy. This is a high-visibility role with progression opportunities.

Key Responsibilities:

  • Drive global regulatory strategy for early-phase programmes

  • Lead IND, IMPD, CTA, and scientific advice submissions

  • Represent company in EMA and national health authority interactions

  • Work cross-functionally with Clinical, Nonclinical, and CMC

Requirements:

  • 7+ years in regulatory affairs within biotech or pharma

  • Experience in early clinical development

  • Strong knowledge of EU and US regulatory environments

Why Join?

  • Be part of a biotech with a high-potential pipeline and global ambitions

  • Lead regulatory strategy with close access to senior leadership

  • Excellent career progression in a science-driven, innovative environment

  • Competitive salary and hybrid flexibility from Munich HQ

Equal Opportunities Employer

Axion is an equal opportunities employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

How to apply:

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