Senior Director, Regulatory Affairs

Shanghai, China   |   full time   |   Job ID: 8290 

Your main responsibilities are: 

• Further develop relationship with local partners, including collaborating on development plans for China, contributing to project governance as BioNTech Regulatory representative for China, advise on development strategy and submission planning, and oversee activities conducted by collaboration partners.    
• Plan and manage the preparation, review process and maintenance of IND, NDA and/or BLA submissions in China, and any other relevant regulatory filing to enable clinical trials and market approval of vaccines, mRNA therapeutics and other biological products.
• Support the writing, organizating and review of application materials according to the relevant requirements and guidelines, contribute to the authoring and approval process of key regulatory filings and coordinate the contribution of all stakeholders and internal team members (both local and global, as needed) to China procedures.
• Contribute to global development plans for BioNTech´s pipeline candidates and marketed products by providing input on the regulatory strategy, requirements and timelines for China regulatory activities.
• Establish and maintain a transparent and trust-based communication and relationship with all relevant regulatory agencies, government departments and local authorities.
• Be responsible for tracking and collecting domestic and foreign drug regulatory policies and regulations, understand and summarize the emerging trends in pharmaceutical laws and regulations to inform local and global colleagues and provide training as needed on new policies and regulations for compliance and risk management.
• Ensure robust GxP compliance and support implementation of quality processes in all regulatory activities. Be responsible for the compliance audit in the process of R&D, and assist in on-site verification, sample inspection and local due diligence activities.
• Liaise with Global Regulatory Affairs to inform global development strategies and align on implementation of regulatory processes and procedures in support of BioNTech´s developments.
• As part of the BioNTech China leadership, support  building local organization reflecting BioNTech´s core values of Passion, Innovation, Unity, and contribute to raising on awareness on best regulatory practices, standards and requirements.

What you have to offer:

• Major in biology or pharmacy, full-time bachelor degree or above, more than 15 years working experience in drug and/or vaccine regulatory affairs and oncology developments. Prior experience in biologics, advanced therapies or cell therapies is a plus.
• Working experience in registration and declaration of biological drugs in China, documented experience for at least one complete registration and declaration of biopharmaceutical drugs, experience with clinical development programs in China.
• Be familiar with the regulatory documents and dossiers such as drug administration regulations for human use and drug registration regulations, and be familiar with the process of biopharmaceutical drug registration and regulatory filings in China to support clinical trials. Be able to write the application review materials and audit the application materials;
• Be familiar with the regulations and application process of biological drug registration and clinical research in China. Working experience with regulatory submissions in support of clinical trials in China. Knowledge and understanding of regulatory environments of  United States and European Union for clinical trial and / or drug registration is preferred but not mandatory;
• Prior experience in a global or foreign pharmaceutical or biotech company would be appreciated.
• Good communication skills in English, business fluent, with good multitask processing ability.
• Good ability of organization, coordination and team management

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 Recruiter.

We are looking forward receiving your application.