Regulatory Affairs Officer
Regulatory Affairs Officer
Main duties and responsibilities:
- Understanding of Regulatory strategy and documentation requirements
- Act as responsible Regulatory Team member for assigned regulatory projects
- Prepare regulatory documentation for DCP, MRP and National applications in line with assigned timelines
- Liaise with various departments to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration
- Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products
- Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities
- Liaise with external Regulatory authorities as required.
- Ensure policies and procedures are properly understood, evaluated and carried out. Make sure modifications are investigated if necessary.
- Preparation of submissions including CMC variation filling.
Experience, skills and qualifications required:
- BSc Degree in Chemistry, Biology or relevant field.
- 1-2 years of experience in Regulatory Affairs / CMC within a Pharmaceutical organization.
- Strong organization skills, multi-tasking and able to meet deadlines
- Effective communication and relationship management
- Knowledge of CMC and global regulatory guidelines
- Fluent in English and good MS Office skills
- Ability to work under pressure, resilience
The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.
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