Regulatory Affairs job vacancy at Gautam Buddha Nagar in HiGlance Labs

About Company: -
We have a challenging and inspiring mission to improve the quality of human life by enabling people to think about their health conscious, feel better and live longer. This mission gives us the purpose to manufacture pharmaceutical, vitamins, and nutrient products that help millions of people around the globe.
We care about the impact having on the people and places touched by our mission to improve health around the world providing wide range of world class products on affordable price!
HiGlance Laboratories registered Office is situated in India's capital New Delhi and many representative offices are established in national regions to give feedback and fast service to our customers.

Roles & Responsibilities: -
1. Compilation and submission of Dossiers as per respective customer/ regulatory body requirement and maintain the records of Dossiers documents.

2. Lifecycle management of product through Dossier submission for renewals/ re-registration of product or filing of variation for change in existing product.

3. To provide response of queries received from customer/ regulatory body through coordination with concern department.

4. Co-ordination for registration samples/ samples required for various studies/ analysis (e.g. Bioequivalence, working reference standard for analysis etc.)

5. Review of Artwork.

6. To prepare material safety data sheet for finished products or working reference standard samples as per the requirement.

7. Application/ Renewal of Product License, Test License, Manufacturing License, GMP-GLP certificate, WHO-GMP certificate, COPP (Certificate of pharmaceutical products) etc.

8. To complete the New Product Introduction checklist with respect to regulatory affairs department activities.

9. 2-3 years of experience required.

10. Must be graduate with B. Pharma or related field.