Bangalore;Officer - Regulatory Affair (1year Contract);B.Pharm; client of Breakthru Appointments

Responsibility;

1. Maintain Records - Archive ad retrieve Manufacturing license,
Test license , Repacking license, Marketing approvals , correspondence
with the Regulatory authorities etc

2. Keep track of expiry of licenses and give a heads up in advance so that the renewal activity can be planned.

3. Artwork review : Checking against regulations, ensure all aspects are correct

4. Ongoing Interaction with contract manufacturers.

5. Follow up of registration applications with the FDA and consultation with them on various issues if required.

6. Compile dossier for submission to Regulatory Authorities

7. Ongoing Interaction with Commercial team

8. Sourcing of challans for submission of fees to regulatory authorities.

9. Screen regulations and literature to input on regulatory strategy

10. Co- ordination with external agencies for delivery of REACH related projects

Qualification Requirment

1. B. Pharm

2. Acquaintance with the Drugs and cosmetics Act

3. Preliminary Knowledge of various regulatory processes

4. Working knowledge of computers

Salary
2.00 - 4.00 lacs

send resumes to: 0265@kamkaz.com