Manager Global Regulatory Affairs - Submission & Publishing APAC

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 + benef