Open for hire at one of the following locations – Mainz Goldgrube, Cambridge, London. - Job ID: 7725

Join our team of pioneers!

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.

Associate Director* Global Regulatory Affairs Development Pipeline

Your main responsibilities are:

• Act as global regulatory lead for assigned development projects, and define and execute Regulatory Strategy from clinical development up to (including) Marketing Authorisation Application
• Plan, prepare and conduct interactions with national authorities and sovra-national agencies (e.g. MPA, PEI, EMA, FDA, as well as WHO when relevant) in the scope of product development incl. market authorisation
• Support the definition of storyline for regulatory application and dossiers through product development and to marketing authorisation. Coordinate preparation, writing and reviewing of documents and dossiers (e.g. briefing books, IBs, MAA, variations)
• Contribute to the set up, adjustment and continuous optimization of regulatory processes, systems and interfaces. Supervision of vendors active in regulatory affairs on behalf of BioNTech
• Regulatory Intelligence: Contribution and monitoring of changes and evolution in the regulatory landscape for therapeutics and/or diagnostics. Analyzing the impact of drug/devices changing regulations for BioNTechs products

What you have to offer:

• University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent)
• At least 7 years of experience in relevant roles/positions
• At least 5 years professional working experience in Regulatory Affairs within a clinical trial setting
• 3 years functional and / or disciplinary leadership experience with convincing track record of leading projects
• Knowledge of multidisciplinary functions involved in drug development
• Knowledge of clinical research and its application to drug development in therapeutic are of relevance such as Cancer
• Very structured, accurate and team-oriented way of working
• Business fluent Englisch is a must

Benefits for you

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

Have we kindled your pioneering spirit?

This vacancy is to be hired at one of the following locations – Mainz Goldgrube, Cambridge, London. Apply now for your preferred job and location through our careers site.

*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!