Director Global Regulatory Affairs (Oncology)

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Mainz, Germany; London, United Kingdom; Munich, Germany | full time

You will act as the Global Regulatory Lead for assigned development projects by defining and executing the Regulatory Strategy including the Health Authority Interaction strategy and developing the storyline for regulatory applications and dossiers during product development up to marketing authorization.

Your main responsibilities are:

• Act as Global Regulatory Lead for assigned development projects and define and execute the Regulatory Strategy from clinical development up to marketing authorization.
• Define the strategy for regulatory interactions for the assigned projects. Plan, prepare and conduct interactions with national authorities and sovra-national agencies.
• Define the storyline for regulatory applications and dossiers through product development up to marketing authorization.
• Coordinate preparation, writing and reviewing of documents and dossiers.
• Contribute to the setup, adjustment and continuous optimization of regulatory processes, systems and interfaces.
• Supervision of vendors active in regulatory affairs on behalf of BioNTech.
• Monitor changes and evolution in the regulatory landscape for relevant product and/or product classes.

What you have to offer:

• University degree in natural sciences followed by 9+ years of working experience in Regulatory Affairs.
• Experience in the development of antibody- and ADC-based cancer therapies.
• Team-oriented and solution-oriented mindset is expected.
• Experience in regulatory strategy planning and proven ability to plan, coordinate and lead activities.
• Knowledge of multidisciplinary functions involved in drug development.
• Business fluent English is a must.

Your Benefits: BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.

How to apply: Apply now by sending us your application documents via our online form.

We are an equal opportunities employer and welcome applications from all qualified candidates.

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