Manager Regulatory Affairs (m/f/d) | Mannheim area / remote | Pharma
In this position, you will work on the approval procedures for preparations at national and international level. You will be in regular contact with Health Authorities and provide regulatory strategy to product lifecycle planning!
What are your tasks as Manager Regulatory Affairs?
Global regulatory life-cycle management for licensed products (e.g. EU national procedures and MRP/DCP)
Provide regulatory strategy to product lifecycle planning
Timely management and preparation of high-quality regulatory documents and submissions (eCTD)
Act as the company's primary point of contact for Health Authorities and establish effective working relationships with regulatory consulting agents
Review of educational and promotional material to ensure compliance with applicable regulations
Coordinate Health Authority response teams
Represent regulatory as member of Project Teams and assure Regulatory Affairs input into designated projects
What does the position offer to you?
Contract: unlimited & full time
Salary: base salary + bonus
Holidays: 30 days / year
Working hours: 40 hours / week
Accessibility: on-site parking and very good public transport connections
Start date: At the next possible time
Position can be filled either on site or remote with ad-hoc traveling and / or regular presence on site (negotiable)
What requirements do you need to bring?
Ph.D. or master's degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology or comparable
At least 3 years' experience in the field of Regulatory Affairs in a global environment
Good experience in Life-Cycle Management (post-authorization with European Health Authorities) as well as EU national and MRP / DCP procedures
Excellent written and verbal communication skills in English; German at least a good B1 would be needed
Excellent communication skills as well as ability to work as a member of a team independently
Very good comprehension, independent way of working, intercultural competence
Contact for application:
Tel: +49 (0)89 / 21 09 49 06