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Senior Regulatory Specialist
وصف الوظيفة
The Senior Regulatory Specialist ensures timely delivery of regulatory activities across multiple projects and dosage forms. This role provides regulatory guidance to various departments and acts as a Subject Matter Expert for specific CMC/regulatory areas.
المسؤوليات
- Independently develop and execute agreed dossier strategy
- Manage multiple projects simultaneously
- Conduct thorough data assessments for dossiers
- Identify and mitigate risks related to submission data
- Review peers’ dossiers and recommend improvements
- Act as subject-matter expert on applicable regulations
- Build and maintain stakeholder relationships
المؤهلات
- Bachelor’s degree in pharmacy, chemistry, biotechnology, or life sciences
- Fluent written and verbal English
- Knowledge of drug development and manufacturing processes