HEAD IRA (INTERNATIONAL REGULATORY AFFAIRS)

DESIGNATION : HEAD IRA (INTERNATIONAL REGULATORY AFFAIRS)

No of Position : One

Experience : B. Pharm / M. Pharm / M. Sc. minimum 12 to 15 years of experience.

Company : Pharmaceutical Company

Salary : As per industry norms and candidates experience

Job Profile :

- Heading the regulatory department of the company and leading a team of executives/Senior executives/Asst.

Manager.

- Must be aware of the latest country specific guidelines for ROW market and capable of planning and

implementing, guiding, supporting, reviewing and finally approving the dossiers and implementing the other

defined activities of the department.

- Coordination with plant for registration and other technical documents.

- Product development report, stability reports, process validations preparation & review.

- Analytical method validation review as per the ICH guideline.

- Drug Master File review.

- Guiding the team for FDCA applications and keeping a track of their timely renewals.

- Technical query response to the various regulatory authorities.

- Check artwork as per country requirements for registration and for commercial.

- Responsible for Post approval after registration for countries.

- Check PD (Product description) after product registration.

- Check final COA before commercial