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).
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)
Professional training or degree in the technical, commercial or pharmaceutical field, or equivalent experience (e.g. CTA, PTA, BTA)
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
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