Immuno-Oncolology Biotech - RA Manager (remote)
I am working with a growing immuno-oncology biotech company based near Berlin. They are expanding due to successes in clinical trials and looking for an experienced RA Manager to join their growing team.
Key Responsibilities:
- Responsible for the preparation and submission of clinical trial or other regulatory related applications
- Communicate with external partners to support company's regulatory affairs projects
- Ensure regulatory compliance of the company's clinical trials, anticipate and navigate regulatory obstacles
- Responsible for site start-up (till greenlight) on the clinical projects
The ideal candidate has:
- 3+ years working in Regulatory Affairs with a focus on clinical trials
- 2+ years working with FDA Regulations
- Experience in study start-up
- Fluent English and German
- This role offers complete remote work flexibility, and can be based throughout Europe with infrequent travel to HQ in Berlin
The company offers a competitive financial package, and the chance to join a world leader in the immuno-oncology space.