Title: Regulatory Operation Manager
Location: Beijing, China
Overview: One of the global biotech firms is currently growing and seeking a Regulatory Operation Manager to join the team. As a Regulatory Operation Manager in this biotech company, you gain the opportunity to oversee cell therapy production and support commercial and clinical requirements.
Responsibilities of a Regulatory Operation Manager:
- Manage the manufacturing of cell therapies and make sure that it complies with cGMP standards
- Developing or updating operational procedures
- In charge of managing production metrics and multiple work centers inside the facility to guarantee the supply of high-quality and compliance products.
- Actively support regulatory inspections, support manufacturing investigations, support and manage change controls, and maintain permanent inspection preparedness
- Promote ongoing improvements and efficiencies within cell therapy Technical Operations, lead facility operating review meetings and take responsibility for a number of department projects.
Requirement of a Regulatory Operation Manager:
- Experienced in eCTD and regulatory operations
- Good team player and interpersonal skills
- Fluent in English and Chinese
- Competitive compensation package
- Excellent regulatory operation opportunities
- Being part of exciting cell therapy research
If you are interested in this Regulatory Operation Manager position, please apply by sending in your CV!