Global Regulatory Affairs Head - Vaccines, Oncology, Autoimmune
Global Regulatory Affairs Head
Innovative fusion protein drug development platform
About Our Client
Our client is China headquartered and globally focused pharmaceutical company managing Clinical and Pre Clinical assets in Immuno-Oncology, Auto Immune and Vaccine area. Currently they are employing around 200 FTE in China, US and Australia across R&D, Biomanufacturing, Clinical, Medical and Manufacturing. They aiming to go IPO in 2021 on a global stock exchange.
Key deliverables for the first year of employment:
- Drive and ensue WHO pre-qualification for COVID-19 vaccines candidate progressing into Global Phase III Clinical studies and initiate EMA submission
- For 2 Oncology assets drive IND application with FDA
- Initiate internal settlement of mature regulatory submission policy and procedures
- Develop worldwide regulatory strategy to optimise label and obtain shortest time to approval by regulatory agencies across multiple locations
- Provides expert advice to internal teams including R&D, Medical, Clinical and Commercial etc. on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug
- Provides leadership to Regulatory Affairs team across product lines and locations
- Represents the company with external organisations through communication with the regulatory agencies (FDA, CFDA, EMA etc.)
- Chairs meetings, prepares internal teams for meetings with relevant authorities at all phases of drug development.
- Leads cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
The Successful Applicant
- Master or PhD in biological science, chemistry or related discipline preferred
- Substantial experience in regulatory affairs functions in leadership role with global or regional coverage (preferred regions include China, Europe, APAC, Latin America, EMEA)
- Regulatory experience preferred with therapeutic area experience in Biologics, Vaccines, Oncology or similar
- Fluent English ability. Chinese language ability will be advantage but not a must for this role
What's on Offer
Successful candidate will be offered competitive salary, bonus and stock option package along with the opportunity to develop within the team of professionals and bring COVID-19 Vaccine to Global Public