Associate Director Regulatory Affairs Commercial Portfolio* Germany
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 Regulatory Affairs Commercial Portfolio* Germany
You will be member of the Regulatory Affairs Commercial Portfolio team and will lead the execution of defined regulatory strategy for commercial products required for local life cycle maintenance of Marketing Authorisations in Germany. In your role, you will work cross-functionally.
Your duties in detail:
- Support definition and execution of local regulatory strategy for commercial products, including maintenance of Marketing Authorisation(s) and drug life cycle management. The strategy needs to consider local German requirements and regulatory commitments, as well as ensure continued alignment with market needs and the further product development post-marketing
- Responsible for defined local regulatory activities starting from Day 1 after initial (centralized) Marketing Authorization approval and continuing through all post-registration activities, which including matters from e. g. Labeling (German product informative texts), Medical Affairs, Pharmacovigilance and CMC. Regulatory activities might involve cooperation with partners for outsourcing or co-developing
- Regulatory submissions to and direct communication with German competent Health authorities (PEI, BfArM) and BMG
- Support of definition of local regulatory processes applied for maintenance of Marketing Authorisation(s) and drug life cycle management
- Report any observed critical Regulatory issues and proactively implement activities for their resolution
What you have to offer:
- Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent
- At least 5 years professional working experience in Regulatory Affairs Germany during registration and/or post-marketing for Biologics, Vaccines and/or Small Molecules
- Profound experience in preparation and revision of Marketing Authorisation Dossiers
- In depth knowledge of local regulatory requirements for medicinal products throughout products life cycle
- Knowledge of multidisciplinary functions involved in registration process and maintenance
- Result-and goal-oriented
- Excellent communication skills in German language
- Good communication skills in English
Benefits for you:
- Flexible Working Time
- Mobile Office
- Work from EU Countries (up to 20 days per year)
- Company Pension Scheme
- Childcare
- Jobticket
- Company Bike
- Leave Account
- Fitness Courses
... and much more.
Have we kindled your pioneering spirit?
Then apply now for our location Mainz Goldgrube and simply send us your application documents using our online form.
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 6300 (please indicate for inquiries)
We look forward to your application!
*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!
BioNTech - As unique as you
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