Associate Director* Global Regulatory Affairs Regulatory Operations (Clinical Trials) in Mainz bei BioNTech AG

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As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

• Manage submissions of EU CTAs according to project plans and as defined in SOPs and work instructions, including entering of data and upload of documents, as well as monitoring of CTIS for Requests for Information (RFIs) and other authorities’ responses in close alignment with the CTIS Lead and other team members, as well as maintenance of CTAs in CTIS and CTIS monitoring and result reporting
• Ensure the EU CTR compliant use of CTIS within a complex multi-stakeholder context, including the definition of roles and responsibilities for Global Regulatory Affairs (GRA) and Global Regulatory Operations (GRO), as well as for other involved stakeholders
• Support the strategic set up and maintenance of governance structures and support the connection to software solutions (CTIS > BNT's Regulatory information and document management system, other safety, clinical systems)
• Continuously support cross-functional improvement of processes for EU CTR compliant key deliverables and CTA submission using CTIS: definition, assessment of impact on users, and alignment. This further includes the constant exchange and alignment cross-functionally and with service providers
• Support the definition and implementation of CTIS User Management concepts and support the identification of training needs and the provision of training

• Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent
• Minimum of 5 years professional working experience in a relevant field in the pharmaceutical industry.
• Sound understanding of processes for CTAs under the EU-CTR including relevant timelines, and deliverables
• Ideally experience in submitting and managing CTAs in CTIS
• Experience in working in complex multi-stakeholder environments according to cross-functional processes.
• Experience in working with global software solutions for planning, creating and tracking of Clinical and/or Regulatory submissions
• Result-and goal-oriented
• Excellent communication skills in English