-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
- Collect, collate and evaluate scientific data from a range of sources
- Develop and write clear arguments and explanations for new product licences and licence renewals
- Prepare submissions of licence variations and renewals to strict deadlines
- Monitor and set timelines for licence variations and renewal approvals
- Work with specialist computer software and resources
- Write clear, accessible product labels and patient information leaflets
- Plan and develop product trials and interpret trial data
- Provide strategic advice to senior management throughout the development of a new product
- Project manage teams of colleagues involved with the development of new products
- Undertake and manage regulatory inspections
- Review company practices and provide advice on changes to systems
- Take part in the development of marketing concepts and approve packaging and advertising before a product's release.

- Deep experience from pharmaceutical industry from a regulatory affairs perspective
- Knowledge of pharmaceutical legislation, relevant guidelines, procedures and
- requirements
- IT skills