Senior Manager, Regulatory Affairs – Submission Lead

This is a fully remote position, open to applicants in Germany.

📋 Description

• Act as the EU Submission Lead for designated clinical trials.

• Serve as the main point of contact for planning and executing submissions.

• Oversee the preparation and submission of initial applications and amendments through CTIS.

• Ensure adherence to regulatory standards.

• Facilitate submission readiness and manage the regulatory filing process.

• Coordinate the timely preparation and submission of Request for Information responses.

⛳️ Requirements

• Master's degree in Life Sciences.

• Minimum of 2 years of experience with clinical trial submissions in the EU via CTIS.

• Familiarity with submissions in non-EU countries is a plus.

• Ability to work independently and possess strong analytical skills.

• Exceptional communication skills in English (at least C1-Level); proficiency in German is an advantage.

🏝️ Benefits

• Job bike.

• Job ticket.

• Health Programs.

• Childcare benefits.

• Relocation allowance.

• Company summer and winter events.