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 recent 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.

📌 Regulatory Manager (Mumbai)
🏢 Fiza Healthcare
📍 Mumbai