Regulatory Affairs Senior Officer

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DEMO Pharmaceuticals

Implement the Regulatory strategy and understand relevant documentation requirements;
Act as responsible Regulatory Team member for assigned regulatory projects;
Review regulatory documentation for DCP, MRP and National applications in line with assigned timelines;
Coach, guide and review deliverables of Regulatory Affairs Officers and Associates;
Liaise with external Regulatory authorities as required;
Ensure policies and procedures are properly understood, evaluated and carried out. Make sure that modifications are investigated if necessary;
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.

BSc Degree in Chemistry, Biology or relevant field;
3+ years of experience in Regulatory Affairs/CMC within a Pharmaceutical organization;
Fluent in English and good MS Office skills;
Strong organization skills, multi-tasking and able to meet deadlines;
Effective communication and relationship management;
Knowledge of CMC and global regulatory guidelines;
Ability to work under pressure, resilience.

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