Shanghai, China | full time | Job ID: 9342
As Director Regulatory Affairs you will act as the Regulatory clinical strategist/GRL for assigned development projects, by defining and executing the Regulatoy Strategy including CDP assessment, the HA interaction strategy and developing the storyline for regulatory applications and dossiers during product development up to marketing authorisation.
Your main responsibilities are:
- Act as regulatory clinical strategist/GRL for assigned development projects, and define and execute Regulatory Strategy from clinical development up to (including) Marketing Authorisation Application.
- Define the strategy for regulatory interactions for the assigned projects. Plan, prepare and conduct interactions with national authorities (e.g. CDE, FDA, TGA etc) in the scope of product development incl. market authorisation.
- Defines storyline for regulatory application and dossiers through product development and to marketing authorisation. Coordinate preparation, writing and reviewing of documents and dossiers (e.g. briefing books, IBs, MAA, variations).
- Represent GRA in cross-functional initiatives for process improvement and with collaboration partners. Contribute to the set-up, adjustment and continuous optimization of regulatory processes, systems and interfaces. Oversee plans of vendors active in regulatory affairs on behalf of BioNTech.
- Monitoring of changes and evolution in the regulatory landscape for relevant product and/or product classes; analyze the impact of new regulations on assigned projects; contribute to build transparent relationships with Regulatory agencies for the assigned projects.
What you have to offer:
- University degree in natural sciences (Medicine, Pharmacy, Chemistry, Biotechnology, Biology or Equivalent)
- More than 12 years working experience in regulatory affairs, new oncology drug development is preferred.
- Experience in CDP assessment and have done real cases for FIH, Phase II or Phase III studies, be capable of identifying risk and finding opportunities is required.
- Experience in PA assessment and knowledgeable to identify “substantial” and “non-substantial” changes per CDE guidelines is required.
- 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.
