Shanghai, China | full time | Job ID: 9341
As Director Regulatory Affairs CMC, you will act as the lead for the assigned development and/or commercial products and/or projects and define and execute the Global Regulatory CMC strategy from pre-clinical stage up to Marketing Authorisation and/or life cycle maintenance.
Your main responsibilities are:
- Act as global regulatory affairs CMC lead for the assigned development and/or commercial products and/or projects and define and execute the Global Regulatory CMC strategy from pre-clinical stage up to Marketing Authorisation and/or life cycle maintenance.
- Define the strategy of the interactions with national authorities and sovra-national regulatory agencies in the scope of CMC aspects for the assigned products. Plan, prepare and conduct all CMC related topics/aspects for the interactions in the scope of products under development up to Marketing Authorisation and/or in the life
- Define the regulatory CMC dossiers strategy, content and appropriateness for the respective development and commercial products (lifecycle maintenance); coordinate the preparation, author (e.g. briefing books and CMC sections in the IB) and review the regulatory CMC submission packages incl. sources documents.
- Implement and apply as well as adjust and continuously optimize harmonized regulatory CMC processes and sytsems. Collaborate with internal and external stakeholder using regulatory CMC standards and processes.
- Regulatory Intelligence: Monitor changes and evolution in the regulatory CMC landscape for medicinal products and analyse the impact of changing regulations on BioNTech´s products and/or assigned projects. (10%)
What you have to offer:
- University degree in natural sciences (Medicine, Pharmacy, Chemistry, Biotechnology, Biology, or equivalent)
- More than 10 years working experience in regulatory affairs, CMC background for biological product is preferred
- Be familiar with ICH guideline for Quality, knowledgeable to China CMC related policies and technical guidelines
- Have done real cases for antibody drugs or/and ADC drugs CMC changes and filings during IND or/and BLA process
- Prior experience in collaborative program would be a plus to this position
- Prior experience in a global or foreign pharmaceutical or biotech company would be appreciated
- Good communication skills and influence in English and Chinese, business fluent, with good multitask processing ability
Your Benefits:
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.
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.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.