Industry - Pharmacueticals
- ensure that the company's products comply with the regulations of the regions where they are distributed.
- keep up to date with national and international legislation, guidelines and customer practices.
- prepare dossiers, documents and samples as per requirement of markets for participation in tenders.
- collect, collate and evaluate scientific data from a range of sources and prepare dossiers as per the market demand in CTD /ACTD formats.
- monitor and set timelines for registrations variations and renewal approvals and submissions.
- write explicit, accessible product labels and patient information leaflets.
- advise country sales managers on regulatory requirements.
- provide strategic advice to senior management throughout the development of a new product.
- manage teams of colleagues involved with the development of new products.
- undertake and manage regulatory internal audits ..
- review company practices and provide advice on changes to systems.
- liaise with, and make presentations to, regulatory authorities.
- follow up with marketing team for marketing authorization, registration data and status.
- take part in the development of marketing concepts and approve packaging and advertising before a product's release.
- Experience in Dossier.