Manager/Director, Technical Regulatory
Roche
full-time
Posted on:
Location Type: Office
Location: Beijing • China
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Job Level
About the role
- Performs the coordination and preparation of document packages for regulatory submissions for new and mature products
- Compiles all materials required in submissions, license renewal and annual registrations
- Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance
- Monitors and improves tracking/control systems
- Keeps abreast of regulatory procedures and changes
- May direct interaction with regulatory agencies on defined matters
- Recommends strategies for earliest possible approvals of clinical trials applications
- Works independently within guidelines and policies, receives minimal guidance
- Acts as a resource for colleagues with less experience and provides functional guidance
- Interact with regulatory agencies on defined matter
- Contribute to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement
Requirements
- Master’s Degree in life science disciplines is preferred
- 3 or more years’ work experience in the pharmaceutical, biotechnology or related industry in CMC, Regulatory, Quality, R&D, and Manufacturing or related
- Experience on generating technical registration dossier for China/EU/USA is preferred
- Analytical development, or MSAT, or manufacture process development, supply chain experience would be a plus
- Filing experience in Regulatory Affairs is a plus
- Knowledge of ICH, WHO, China regulations and guidance
- Knowledge of regulations and guidelines of other major markets (e.g. FDA, EMA) is a plus
- Proficiency with a wide range of data/information (CMC, clinical, non-clinical)
Benefits
- Our culture encourages personal expression, open dialogue, and genuine connections
- Embraced for the unique qualities you bring
- Valued, accepted and respected for who you are
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionstechnical registration dossieranalytical developmentmanufacture process developmentsupply chain experiencefiling experience in Regulatory AffairsCMCclinicalnon-clinical
Soft skills
coordinationindependent workfunctional guidancecommunicationproblem-solving
Certifications
Master’s Degree in life science disciplines