Job Description
Our client is an international pharmaceutical manufacturer with Headquarter in continental Europe. It is specialized in generics with a wide range of dosage forms. Our client commercializes worldwide more than 600 products for different therapeutic areas. 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.
Our client is an international pharmaceutical manufacturer with Headquarter in continental Europe. It is specialized in generics with a wide range of dosage forms. Our client commercializes worldwide more than 600 products for different therapeutic areas. 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).
Description
- 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.