Specialist Global Regulatory Affairs
Mainz, Germany | full time | Job ID: 9339
You will support the Global Regulatory Affairs (GRA) Development Pipeline team in the planning, preparation, and recording of regulatory submissions. In your role you will closely work with the Global Regulatory Leads (GRLs) in managing clinical trials and product development from a regulatory perspective. Moreover, you may act as the primary contact for local regulatory partners or collaborators (e.g. license partners, affiliates, local regulatory vendors, CROs).
Your main responsibilities are:
- Prepare regulatory documentation in close cooperation with the GRL and GRA internal and external stakeholders for all regulatory submissions managed by the GRA Development Pipeline team
- Ensure good documentation practice
- Coordinate provision of requests from local regulatory partners to the responsible internal functions
- Support preparation of responses to health authority inquiries
- Track regulatory activities, enter and maintain data in respective databases for regulatory status, planning activities, and publishing
- Support GRA process documentation activities and contribute to the improvement of internal GRA processes
- May prepare and update presentations in close cooperation with the GRL
- Support regulatory meetings as needed (e.g. schedules meetings, prepares minutes)
What you have to offer:
- Vocational training in the technical or pharmaceutical field or equivalent experience (e.g., chemical, pharmaceutical, or biological technical assistant)
- Approximately 3 years professional working experience in Regulatory Affairs, incl. clinical trial initiation and maintenance, regulatory procedures and requirements
- Fluent command of spoken and written English
- Advanced computer skills, in particular good knowledge of standard office software (Word, Excel, Adobe Acrobat) and electronic document management technology
- Good interpersonal and organizational skills
- Ability to work in a multi-cultural international environment
- Ability to think ‘analytically’ and convey complex concepts in an understandable manner
- Attention to details
Your Benefits:
It's our priority to support you:
- Your flexibility: flexible hours | vacation account
- Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
- Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
- Your health and lifestyle: Company bike
- Your mobility: Job ticket | Deutschlandticket
- Your life phases: Employer-funded pension | Childcare
Apply now - We look forward to your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).
Job ID 9339 (please always specify if you have any questions)
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.