Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
6 Years
Description
- To provide CMC related strategic regulatory input for the assigned projects/products.
- Build, or provide input to, submission strategy documents by defining variation type, data required to support submission, and submission documents required for the submission package. Review and approve published output.
- In conjunction with the Global Regulatory Lead (GRL), guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of all markets is collected and submitted.
- Review and, if necessary, write and edit individual CMC submission documents/CMC dossier sections to support regulatory submissions.
- Maintain registration tracking information and assist in the development of good document management practice standards.
- Work closely with global RA and, regional RA’s to address questions from regulatory authorities.
- In support of key brand CMC variations, proactively provide CMC related regulatory advice and assessment of impact to product dossiers. Advise project teams accordingly.
- To support QA during audits and inspections as required.
- To keep oneself updated on CMC related guidelines.
Qualifications
Highest qualification: University
- Bachelor's Degree and 6+ years of experience.
- Experience in a diagnostic, pharmaceutical, or medical device industry.
- Ability to prioritize, plan & evaluate deliverables to established strategic goals.
- Demonstrated experience of operating in a highly-regulated environment. Capable of applying analytical skills in a CMC regulatory environment.
- Demonstrated knowledge & experience in scientifically related field e.g. pharmaceutical sciences, chemistry and analytical sciences.
- Experience in electronic document management and Quality management systems.
- Knowledge of international CMC regulatory requirements.