Regulatory Manager

Job description

Position - RA Manager

Location - Andheri East (Mumbai)

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 clear, 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.

Male Candidate Required.