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Drug Regulatory Affairs

2 weeks ago

Ludhiana, Punjab, India Randstad Full time US$ 50,000 - US$ 1,00,000 per year

Role & responsibilities :

Uploading the documents on SUGAM portal and on the portals of other State Regulatory

Authorities.


• Handling and responding to all the product specific queries to the related drug departments.


• Ensuring overall compliance to domestic regulatory requirements.


• Co-ordination with respective departments.


• Maintaining familiarity with company product ranges.


• Keeping up to date with changes in regulatory legislation and guidelines.


• Ensuring that quality standards are met and submissions meet strict deadlines.


• Maintain high levels of accuracy, meet tight deadlines.


• Management of Data.


• Preparing DRA's MIS presentation (Quarterly basis) to management.

Preferred candidate profile