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Job Description
- Coordinate and document internal license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.
- Ensure that a company's products comply with the regulations of the regions where they want to distribute them.
- Keep up to date with national and international legislation, guidelines and customer practices
- Develop and write clear arguments and explanations for new product license and license renewals
- Prepare submissions of license variations and renewals to strict deadlines
- Monitor and set timelines for license variations and renewal approvals
- Write clear, accessible product labels and leaflets
- Advise scientists and manufacturers on regulatory requirements
- Undertake and manage regulatory inspections
- Review company practices and provide advice on changes to systems
- Liaise with, and make presentations to, regulatory authorities
Job Requirements
- Education: Pharmacist, Veterinary or Science
- +3 Years of Experience
- Good knowledge for Regulatory Affairs Procedures (Pharma & Medical devices)
- Good communication skills
- Time management skills
