VP* Global Regulatory Affairs - Development Pipeline
Open for hire at one of the following locations – Mainz Goldgrube, Cambridge Erie Street, London. - Job ID: 5462
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.
VP* Global Regulatory Affairs - Development Pipeline
Your main responsibilities are:
- Define and establish overarching regulatory approaches across all product classes and through all development phases. Supervise and endorse global regulatory strategies for pipeline candidates and ensure alignment with corporate goals and priorities
- Supervise and endorse the strategy for interactions with national authorities and sovra-national regulatory agencies, and ensure alignment with the Company position
- Endorse the authoring strategy, storyline, and content appropriateness for key regulatory documents and dossiers for all products in the respective development stage. Ensure transfer of knowledge across all projects and facilitate alignment of regulatory plans and consistency through the pipeline, including close alignment with other Global Regulatory Affairs functions
- Lead and develop the Global Regulatory Affairs - Development Pipeline unit, including education and training of team leads in accordance to BioNTech cultural values to guarantee that experiences and state-of-the-art regulatory know-how are available to support drug development as required
- Monitor and shape evolving regulatory landscape in areas of interest for BioNTech
What you have to offer:
- University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) followed by 15+ years of experience in relevant roles/positions
- Experience in regulatory strategy planning and proven ability to plan, coordinate and lead regulatory activities on global scale
- At least 10 years working experience with leadership roles in Regulatory Affairs, including global team responsibility
- Proven ability to serve as a team leader, including people and process development and management skills
- Good scientific understanding of immuno-oncology and immunology; knowledge of clinical research and its application to drug development in therapeutic area of relevance
- Experience with oncology developments through all development phases, including market approval.
- Additional experience in infectious diseases vaccines developments and/or rare diseases is a plus
- Experience in the development of biological and / or advanced therapies / gene therapy products preferable
- Team-oriented and solution-oriented mindset is expected
- Business fluent English 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 Erie Street, 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!