Responsibilities:
Overseeing the planning, coordination, and management of regulatory documentation activities
Preparing, coordinating and supervising regulatory submissions
Reviewing product conformance and assuring compliance
Preparing authorization documents, reauthorization, response to requests and variations for the medical products
Preparing the documents for notification / response to requests / updating food supplements;
Registration and updating the cosmetic products on CPNP
Examining, identifying, and interpreting relevant regulatory guidelines
Maintaining contact with the National Medicines Agency (NAMMD), National Research and Development Institute for Food Bioresources, the Ministry of Health.
Keep up-to-date with changes in regulatory legislation and guidelines developed by the National Medicines Agency, the Ministry of Health (food supplements), National Research and Development Institute for Food Bioresources (food supplements) and medical devices on the activity of Regulatory Affairs;
Implement different strategies in order to meet evolving regulatory initiatives.
We offer:
Motivational salary package
Private Medical Insurance
Meal tickets
A dynamic work environment with a culture that is open, innovative and performance-orientated