Senior Director Global Regulatory Affairs CMC
Open for hire at one of the following locations – London, Cambridge Erie Street, Mainz K1. - Job ID: 7050
Become a member of the BioNTech Family!
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.
Senior Director Global Regulatory Affairs CMC
In this position, you will lead all aspects of Global Regulatory Affairs CMC for the mRNA-based individualized neoantigen-specific immunotherapy (“iNeST”) in a clinical program in order to bring innovative medicinal products on the market. The iNeST immunotherapies are investigational individualized cancer therapies tailored to a specific patient’s tumor and is being jointly developed by BioNTech and Genentech. Furthermore, you will lead (functional and line management) the Global Regulatory Affairs CMC team of the iNeST / IVAC platform and support Regulatory CMC activities for all platform products. As you guide the products along this exciting path, you will establish new regulatory routes and define requirements for these next generations of therapeutics. You will also get the opportunity to act globally and work cross-functionally.
Your main responsibilities are:
- Define and execute the Global Regulatory CMC strategies for the respective products in i) development towards global Marketing Authorisation, and ii) post-marketing phase
- Act as global regulatory affairs CMC lead for assigned late stage or complex development and/or commercial products and/or projects
- Define the strategy and lead the interactions with national authorities and sovra-national regulatory agencies in the scope of CMC aspects for the assigned products
- Oversee interaction strategies for all products of the IVAC platform and ensure alignment within the product group
- Define and lead the regulatory CMC dossiers strategy, content and appropriateness for the respective development and commercial products (lifecycle maintenance); coordinate the preparation and review the regulatory CMC submission packages incl. sources documents
- Contribute to strategy and ensure implementation of harmonized regulatory CMC processes and systems as well as adjust and continuously optimize them
- Collaborate with internal and external stakeholder using regulatory CMC standards and processes
- Regulatory Intelligence: Contribute to the forming regulatory CMC landscape
- Monitor changes and evolution in the regulatory CMC landscape for medicinal products and analyze the impact of changing regulations on BioNTech´s products and/or assigned projects
What you have to offer:
- Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
- At least 15 years professional experience in Global Regulatory Affairs CMC during clinical and/or registration for Biologics
- Extensive experience in preparation and revision of regulatory CMC documents
- Knowledge of CMC drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development and manufacturing
- Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment
- Excellent communication skills in English and German
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.
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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 – London, Cambridge Erie Street, Mainz K1. 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!