Regulatory Affairs Manager (f/m/d)

Firmenprofil

Since a few years our client has also expanded its operations to Germany. For this, we are looking for a Regulatory Affairs Manager (f/m/d) with stakeholder experience with the German and European local authorities.

• Coordination of activities for the new submissions of regulatory applications.
• Procedural management of European approval procedures (MRP/DCP/RUP) including life cycle management.
• Communication with European regulatory authorities (EU/EEA).
• Creation, revision of texts (SmPC, PIL, labelling) and regulatory review of mock-ups
• Coordination of regulatory activities in consultation with headquarter and service providers.

• University degree in natural sciences, preferably pharmacy, biology, or chemistry.
• 5 + years of management experience in the field of regulatory affairs within the EU.
• Several years of professional experience in the preparation and implementation of EU procedures (MRP / DCP).
• Experience in creating eCTD sequences.
• Ability to work in a team, service orientation
• Process-oriented, analytical and solution-oriented thinking
• A structured, reliable and responsible way of working paired with a hands-on mentality
• Organizational talent, combined with very good communication skills and a high level of personal responsibility
• Very good language skills in spoken and written German and English.
• Confident use of MS Office programs.

• A dynamic and inclusive work environment with opportunities for growth.
• Competitive salary and benefits package.
• Opportunity to work on innovative projects with global impact.