Manager Regulatory Affairs CMC Authoring
Open for hire at one of the following locations – Mainz Goldgrube. - Job ID: 5404
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 Regulatory Affairs CMC Authoring
You will author global quality regulatory documents and provide input into the development of the regulatory CMC strategy for the assigned project(s) in different stages of development, including pre-clinical, Ph I, Ph II, Ph III, initial registration and post-approval stages.
Tasks:
- Author global quality regulatory documentation for assigned project(s) in a timely manner and according to the relevant procedures
- Support definition and establishment of platform approaches to preparation of quality regulatory documentation used in development, registration and post-approval stages
- Support alignment of structure and contents of quality regulatory documentation across company platforms
- Contribute to development of regulatory CMC strategy for the assigned project(s)
- Liaise with relevant stakeholders to facilitate preparation of quality regulatory documentation and strive to optimize/simplify the authoring processes and accelerate the authoring timeline
Requirements:
- Degree in biochemistry, biology, chemistry, pharmacy or equivalent
- 3+ years of professional experience in global regulatory affairs CMC focusing on Biologics, Vaccines and/or Small Molecules
- Extensive experience in authoring of regulatory CMC documents for clinical trial applications (e.g., quality parts of INDs/IMPDs) and/or marketing authorizations (e.g., quality parts of variations, BLAs, MAAs)
- Solid knowledge of product life cycle management and understanding of scientific principles and regulatory CMC requirements relevant to global drug development
- Very good knowledge of the relevant laws and guidelines
- Organizational talent, analytical and conceptual skills as well as excellent communication skills in English (written and spoken)
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. 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!