Job Description

1) Responsible for obtaining approval for new pharmaceutical product

2) Updating legal or regulatory knowledge

2)Learn the regulations that apply to the products in said subfield

3)Compilation of Dossier as per Country requirement i.e. CTD,ACTD

or Country Specific .

4)Co-ordination with F & D, BD, QA,QC, Purchase as per relevant

Department for Document requirement

5)Handling of Query as per Ministry of Country

6) Reviewing documents required for submissions to ensure they are

appropriate for submissions.

7) Maintained RA product files to support compliance with regulatory

requirements.

8) Provided regulatory support for currently marketed products as

necessary.

9) Maintains status registration of each country per distributor or

representative agent of each product line.

10) Variation filing for product as per country guideline

11) Reviewing & checking of Artwork as per country requirement.

12)Responsible for the interpretation, direction, determination, and

reporting of regulatory agency requirements.

13) FDA Application : Product Permission, Free Sale Certificate,

Certificate of Pharmaceutical Product, Test License, Renewal

Manufacturing License for Own & Loan.

Job Type: Full-time

Pay: ?300,000.00 - ?500,000.00 per year

Benefits:

Health insurance Provident Fund
Schedule:

Day shift
Supplemental Pay:

Yearly bonus
Work Location: In person