Regulatory Affairs

5 days ago


Andheri Mumbai Maharashtra, India Fiza Healthcare Pvt Ltd Full time

Regulatory JD
- 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.
- Experience - 5 to 7 Years.

Pay: ₹30,000.00 - ₹35,000.00 per month

Schedule:

- Day shift

**Experience**:

- total work: 4 years (preferred)

Work Location: In person



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