IRA - Officer - Puniska Injectables

Role & responsibilities

1. To Prepare Dossier for export Registration.

2. To Compile document for Export registration.

3. To arrange & send samples for Export Registration.

4. To verify the availability of Product Licenses at site and its timely renewal.

5. Licensing with State & Central Licencing authority for getting Licence / certificates.

6. To Study scientific and legal documents to check they meet legal requirements.

7. To serve as channel of communication to the project team for approving the product.

8. To obtain approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product in the market.

9. To study & comply prescribing information (label’) for the intended product of different market along with all required information of product, e.g., date of manufacturing, expiry date, and ingredients for new & existing products.

10. To offer support on development of product, manufacturing, registration and marketing along with regulatory controls.

11. To develop and maintain effective verbal and written communication during reply and response to queries arising during new drug application (NDA)/investigational new drug application (INDA)/abbreviated new drug application (ANDA) filing.

12. To complete record data of company’s product and maintain the records of therapeutic products in agreement with current regulations and guidelines.

13. To maintain reports and assemble information concerning adverse drug reactions of any product and to help the research and development department to overcome it.

14. To report post-marketing surveillance of new product.

15. To Deliver continuous training to the associated personnel for maintenance of records and reports, for pilot plant, research and developments to facilitate the audits and inspections.

Preferred candidate profile

M. Pharm with 2 to 4 Years Experience in dossiers preparation and submission

Perks and benefits