- 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 patient information 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
- Specify storage, labelling and packaging requirements.
|
