(Senior) Director Global Regulatory Affairs Development Pipeline - Project Lead
Open for hire at one of the following locations – Mainz Goldgrube, Cambridge Erie Street. - Job ID: 6946
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 Development Pipeline - Project Lead
Your purpose on this position is to lead all regulatory activities required for development of investigational medicinal products toward marketing authorisation for global markets. Your main responsibilities are:
Your Tasks:
- Act as global regulatory lead for assigned development projects, including concomitant development of diagnostics, and define and execute regulatory strategy from clinical development up to marketing authorisation
- 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 scope of product development incl. market authorisation
- Define regulatory content of regulatory applications and dossiers for product development, marketing authorisation and maintenance; activities include coordination of preparation, writing and reviewing of documents and dossiers (e.g. briefing books, IBs, MAA, variations)
- Set up, adjust and continuously optimize regulatory processes and interfaces (internal and external); supervise vendors in regulatory affairs on behalf of BioNTech
- Regulatory Intelligence: Monitor changes and evolution in the regulatory landscape for therapeutics and/or diagnostics; analyse the impact of drug/devices changing regulations for BioNTech's products; collect, evaluate and disseminate relevant regulatory updates on competitors' developments
What you have to offer:
- University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) followed by 9+ years of experience in relevant roles/positions
- Experience in regulatory strategy planning and proven ability to plan, coordinate and lead activities
- Experiences in the field of biological products preferable
- Knowledge of multidisciplinary functions involved in drug development
- Knowledge of clinical research and its application to drug development in therapeutic area of relevance such as Cancer and Infectious diseases
- Very structured, accurate and team-oriented way of working
- 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 ans 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. 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!