Associate Director/Sr. Manager, Regulatory Affairs - Development pipeline

Beijing, China   |   full time   |   Job ID: 9672 

Goal:

Act as the regional regulatory lea d to be in charge of assigned development projects, by defining and executing the Regulatory Strategy including the HA interaction strategy and developing the storyline for regulatory applications and dossiers during product development up to marketing authorisation

Your main responsibilities are:

• Managing regulatory aspects for assigned development projects through all phases of clinical trial
• Supporting or participating in China regulatory strategy assessment and ensuring the regulatory strategy implementation including dossier preparation, China submissions for IND/PA/Other variations etc, HA interaction, IR communication, RtQ submission etc, coordinate preparation, writing and reviewing of dossiers, and make sure the filing is in compliance with latest requirement, standards and aligned timeline
• Supporting 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)
• 5-10 years professional working experience in Regulatory Affairs in relevant roles/positions, new oncology drug development is preferred
• Be familiar with CDP assessment and have done real cases for FIH, Phase II or Phase III studies, be capable of identifying risk and finding opportunities
• Be familiar with PA assessment and knowledgeable to identify “substantial” and “non-substantial” changes
• 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.