Job Details
Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:
Skills And Tools:
Job Description
- Coordinates, prepares, assembles & presents the documentation required for submission to regulatory authorities in order to register the company’s new products and maintain existing registrations.
- Keeps abreast of current regulatory knowledge, trends, developments, legislation & guidelines.
- Ensures that the company strictly follows government rules and regulations.
- Takes part in coordinating the planning, scheduling, preparing and assembling of some regulatory projects and submissions.
- Prepares regulatory documentation required for registration of the company’s new products and maintenance of existing ones.
- Prepares regulatory documentation required for submissions of products’ variations along their life-cycle.
- Interfaces with other departments to provide regulatory advice and obtain the necessary documents in accordance with regulatory authorities guidelines.
- Submits regulatory documentation to regulatory authorities within the specified time-frame, negotiates and communicates effectively to obtain timely product approvals.
- Maintains regulatory files in a format consistent with requirements.
- Documents properly, tracks and stores regulatory documents.
- Acts as regulatory representative in different internal committees.
- Creates regulatory Standard Operating Procedures, as necessary.
Job Requirements
- Bachelor Degree in Pharmaceutical Sciences.
- 0 to 2 experience in regulatory position.
- Very good command of English language.
- Proficiency in MS Office: Word, Excel, PowerPoint.
