Description
We are looking for an
International DRA Project Manager (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Provide regulatory strategy for the international countries (outside the following countries: US, EU, Canada, Japan, Australia, New Zealand and Switzerland)
- Maintain regulatory knowledge for international countries (new registrations, variations & renewals of marketed products)
- Liaise and coordinate all documentation, submissions and activities with affiliates for NCE dossiers and life cycle of marketed products
- Respond to health authority questions in coordination with Global DRA Project Leader and project teams
- Coordinate the archiving of submitted registration dossiers and other relevant health authority communication
- Evaluate and review the regulatory activities of potential and existing business partners contracts and quotations
Your qualifications
- Degree in life science and profound experience in International Drug Regulatory Affairs
- Knowledge and experience of global regulatory processes
- Ability to work in multicultural environment
- Excellent communication, interpersonal, negotiation and problem solving skills
- Capable of working independently as well as effective team player
- Accuracy and good project management skills
- Excellent command of spoken and written English, other languages are of advantage
Skills:
- Regulatory affairs manager