The regulatory affairs (RA) department is responsibile for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.
The RA department plays an important role in giving advice to the project team on how best to interpret the rules
Our responsibility is to keep abreast of current legislation, guidelines and other regulatory intelligence
We serves as the interface between the regulatory authority and the project team, and is the channel of communication with the regulatory authority as the project proceeds, aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product.
- studying scientific and legal documents
- gathering, evaluating, organising, managing and collating information in a variety of formats
- maintaining familiarity with company product ranges
- keeping up to date with changes in regulatory legislation and guidelines
- offering advice about company policies, practices and systems
- obtaining marketing permission
- outlining requirements for labelling, storage and packaging
- liaising and negotiating with regulatory authorities
- providing advice about regulations to manufacturers/scientists
- writing comprehensible, user-friendly, clear product information leaflets and labels
- ensuring that quality standards are met and submissions meet strict deadlines
- preparing documentation.
- Maintenance of marketing licenses, permits and other compliance related activities through the life of a products
- Preparation of product Registration Dossier packages and submissions
- Approval of domestic and international medicines
- Regulatory compliance with international health authorities in all markets