Associate Director Global Regulatory Affairs CMC
Open for hire at one of the following locations – London, Mainz K1. - Job ID: 6617
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.
Associate Director Global Regulatory Affairs CMC
Through your innovation, passion and unity with your colleagues you can become a pioneer in our Global Regulatory Affairs Team. In this position, you will lead all aspects of Global Regulatory Affairs CMC for Investigational Medicinal Products in the FixVac clinical program in order to bring new medicinal products on the market. 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:
- Act as global regulatory affairs CMC lead for the assigned development products in alignment with the Global Regulatory Affairs CMC strategy
- Plan and prepare all CMC related aspects for interactions with national authorities and supra-national agencies in the scope of products under development up to Marketing Authorisation
- Execute the defined regulatory CMC dossier strategy incl. defined content for products under development; coordinate preparation, author (e.g. Investigational new drug applications, investigational medicinal product dossiers, briefing books for scientific advice, CMC sections in the IB and response to health authority review questions) and review the regulatory CMC submission packages incl. sources documents
- Apply harmonized regulatory CMC processes and systems as well as contribute to their adjustments and continuous optimization. Collaborate with internal and external stakeholders using regulatory CMC standards and processes. Manage regulatory compliance activities (i.e. periodic regulatory reporting, review of technical documents, regulatory assessments on deviations, CAPAs & change controls) for the assigned products
- Monitor changes and evolution in the regulatory CMC landscape for medicinal products and analyse 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 9 years professional experience in Global Regulatory Affairs CMC, supporting early and late phases of clinical development and new registrations for Biologics, Vaccines and Small Molecules
- 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.
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 – London, 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!