Regulatory Affairs Executive

Position: Regulatory Affairs Executive

Location: Andheri (E)

Role & responsibilities

• 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.

Preferred candidate profile

• Qualification required: Graduate in Pharmacy/ Science

Post graduate in Pharmacy/ Science

• Experience required: 04 to 06 years in preparing dossiers for ROW market.
• Should be experienced in preparing country specific dossiers.
• Well versed with country specific guidelines.
• Fluent in communication.
• Candidate should be living around Andheri or should be comfortable travelling to Andheri (E).