Not specified; details provided later in hiring pr...
Not specified
Master's degree in life science disciplines
3+ years experience in pharmaceutical or biotech industry
Knowledge of ich, who, and china regulations
Roche is seeking a Manager/Director of Technical Regulatory in Beijing to oversee regulatory submissions for pharmaceutical products, ensuring compliance with local and global regulations. The ideal candidate will possess a Master's degree in life sciences and at least three years of relevant experience in regulatory affairs, CMC, or related fields
Job Summary
The role involves preparing high-quality CMC regulatory documents for local and global filings in accordance with Roche corporate standards.
Candidates will manage regulatory aspects of change control and serve as a liaison with local health authorities.
Roche fosters a culture of personal expression and open dialogue where every voice matters to prevent, stop, and cure diseases.
Matching Summary
Match Score: 85
Roche is seeking a Manager/Director of Technical Regulatory in Beijing to oversee regulatory submissions for pharmaceutical products, ensuring compliance with local and global regulations. The ideal candidate will possess a Master's degree in life sciences and at least three years of relevant experience in regulatory affairs, CMC, or related fields.
Salary
Not specified; details provided later in hiring process based on primary location
Skills & Requirements
Must-have
Master's Degree in life science disciplines
3+ years experience in pharmaceutical or biotech industry
Knowledge of ICH, WHO, and China regulations
Nice-to-have
Experience generating technical registration dossier for China/EU/USA
Analytical development or MSAT experience
Filing experience in Regulatory Affairs
Key Requirements
Master's Degree in life science disciplines
3 or more years work experience in pharmaceutical/biotech