MANAGER/SR.MANAGER-REGULATORY AFFAIRS (APIs)

8 - 10 Years
Mumbai

Job Description

1. Planning, execution and submission of dossiers.
2. Preparation of new DMFs., CEP applications and their amendments/revisions.
3. Interacting with regulatory authorities for approval of new and existing applications as well as reviewing and preparing amendments for deficiencies.
4. Co-ordination with R&D team for setting specifications, formula clearance, proportion similarity etc. Monitoring new product development procedure and review the R & D documents during development.
5. Co-ordination with Packaging Development for planning, design and construction of new.
6. Response to queries of agencies/customers.
7. Registering DMFs in various countries as required by Marketing.
8. Providing prompt documentation support to Marketing Department.
9. Co-ordination with manufacturing Plant, R & D, QA/QC.
10. Keeping update with latest reguatory guidelines.

Salary: INR 8,00,000 - 10,00,000 P.A.

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager

Employment Type:Permanent Job, Full Time

Key Skills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:B.Pharma - Pharmacy, B.Sc - Any Specialization

PG:MS/M.Sc(Science) - Any Specialization

Company Profile

Kopran Ltd
An Indian Multinational Pharmaceutical Company with state of the art Plants for the manufacture of Active Pharmaceutical Ingredients and Finished Dosage Forms, having exports to over 50 countries.
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Contact Company:Kopran Ltd