Manager Global Regulatory Affairs - Submission & Publishing APAC
Beijing, China | full time | Job ID: 11588
Your main responsibilities are:
• Submissions: Conduct compilation and publishing of dossiers for Health Authorities in the APAC region including submission itself, all in line with BioNTech standards and following established processes as well as within agreed timelines as required by GRA and other stakeholders.
• Scope: Submissions related to clinical development activities, marketing authorisations and post-approval life-cycle management.
• Expertise: Act as Subject Matter Expert for APAC pre- and post-marketing submissions and continuously keep abreast of regulatory requirements in this region. Communicate changes in business-critical legislation/guidance relating to APAC submissions to line management in a timely manner.
• Systems & Processes: Contribute to set-up, implementation and documentation of systems and processes for submissions in APAC region. Author and conduct training for processes and system relevant for GRO activities in the APAC region. Proactively identify opportunities for business process improvements.
• Issue Management: Proactively notify the GRO management about resource or technical issues potentially impacting deliverables.
• Cross-functional: Strengthen relationships with stakeholders (APAC and global) and exhibit an understanding of their needs in order to develop and maintain robust processes and facilitate good communication and close alignment with global GRO activities.
What you have to offer:
• Minimum of 3y relevant professional experience in relevant field, or degree in a technical, science or pharmaceutical field plus 2y relevant professional experience
• Proven success in working in a team
• 2+ years experience publishing regulatory submissions incl. eCTD experience in the APAC region
• Significant experience with electronic document management systems
• Fluency in spoken and written Mandarin and English
• Attention to detail and accuracy
• Excellent organisational skills and the ability to work to tight deadlines
• Flexibility and the ability to re-prioritise workload
• Open minded, willing to learn, and sound judgement
• Excellent verbal and written communication skills
Your benefits and remuneration:
If the position is filled in the US, the Expected Pay Range is XXX,XXX/year to XXX,XXX/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
Compensation at other locations may vary significantly.
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.