Associate Director – Regulatory Science
We are looking for an experienced person in scientific and regulatory writing, clinical development and/or regulatory affairs. Experience in regulatory and scientific pharmaceutical writing is required. The new member of our team will be involved in various European procedures concerning scientific aspects of medicinal products and management of the team of Scientific Specialist from scientific perspective.
The role will be responsible for the following:
- Providing assessments on the safety and efficacy of medicinal products in the preauthorization and post authorization phase, creates assessment reports, implements comments from the regulatory authority.
- Participating in Scientific advices and other interactions with regulatory agencies
- Providing feedback to the members of the team regarding scientific outputs
- Independently evaluating the documents from the pharmacovigilance department (PSUR, DSUR, RMP etc) in conjunction with the Director of Pharmacovigilance
- Actively participating in the development and implementation of company Quality Management
- Participating in workshops or trainings outside the country
We offer the following conditions:
- Competitive salary with very attractive performance based bonus programs
- Personal bonus based on performance
- Contribution to lunch
- Contribution to insurance (life/pension)
- 20 days of paid holiday
- Young, motivated and international team of colleagues
- Continuous specialized training
If you are interested in this position, please send your CV and motivation letter to firstname.lastname@example.org.