Manager Global Regulatory Affairs (Development Pipeline)

Open for hire at one of the following locations –  Mainz Goldgrube. - Job ID: 7339 

 

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.


 

Manager Global Regulatory Affairs (Development Pipeline) 

 

You will support the Global Regulatory Affairs Development Pipeline team in the planning and execution of defined regulatory activities required for managing clinical trials and product development from a regulatory perspective. In your role, you will act globally and work cross-functionally.

 

Your main responsibilities are:

 

  • Support and/or attend regulatory subteam meetings for the assigned projects as global regulatory affairs delegate
  • Establish and maintain proper regulatory processes for the regulatory handling and life cycling of clinical trials worldwide, in alignment with Global Regulatory Operations and Clinical Research
  • Organize as appropriate, to ensure regulatory documentation is properly maintained according to internal SOPs, regulatory requirements and best practice
  • Manage the regulatory submission process from preparation phase to approval, oversee maintenance of a repository of regulatory documentation according to internal procedure and best practices
  • Work with (Sr) Directors on the execution and management of the regulatory strategy for the assigned projects, provide input to the relevant development plans as needed
  • Support of review of key study core documents and all types of regulatory documentation (quality, safety, efficacy, and labeling), for CTAs and INDs

 

What you have to offer:

 

  • Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent
  • At least 3 years professional working experience in Regulatory Affairs within a clinical trial setting
  • Experience in preparation and revision of CTAs, INDs, Scientific Advices and US and EU designation applications is a plus
  • Solid knowledge of regulatory requirements and procedures in the US, EU/EEA, and UK throughout the product’s life cycle
  • Knowledge of multidisciplinary functions involved in clinical trials and pharmaceutical development
  • Result-and goal-oriented
  • Excellent communication skills in English


 

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 GoldgrubeApply 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!