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.