Regulatory Affairs Specialist

Duties and Responsibilities:
- Preparing, submitting and filling of regulatory documents.
- Experienced in evaluation and filing of New products registration dossiers of imported DRUG PRODUCTS to FDA in coordination with Foreign based Suppliers.
- Ensuring the licenses of the Food and Drug Administration (FDA) are all valid and updated.
- Facilitates and complies with FDA inspections.
- Performs the duties of Responsible Pharmacist for Warehouse as per standards of WHO’S Good Distribution and Good Storage Practice. Acts as Quality Assurance officer.
- Coordinating with Sales Team for the new product being developed

Qualifications:
- A registered Pharmacist
- Regulatory Affairs experience is a plus
- Excellent communication skills both in writing and speaking
- Excellent interpersonal skills
- High level of detail-oriented focus