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Drug Regulatory Affairs Executive
6 days ago
Job description - Executive - Drug Regulatory Affairs
Roles and Responsibilities
Planning, compilation, review and submission of dossiers related to export.
Review of labels of Drugs, Cosmetics and Medical Devices and ensuring their full compliance with the applicable Rules and Regulations.
Handling and responding to all the product specific queries.
Performing Root cause and analysis and preparing replies to the show cause notices
Ensuring overall compliance with 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.
Preparation and submission of DRA's Performance review plan (PRP) (Quarterly basis) to Management.
Maintaining Product Registration Certificates received.
Timely answering Queries raised by Health Authorities of respective countries and customers.
At least 3 years of experience in Domestic Drug Regulatory Affairs.
Education: Science Graduate / B.Pharma / M. Pharma.
Industry Type: Pharma.
Good knowledge about the Indian Drug Regulatory System.
Knowledge of Dossier Modules, understanding of GMP standards and regulatory guidelines.
Good Interpersonal skills
Command over written and verbal English communication.
Proficient in computer skills especially MS Office and adobe PDF.
Commitment and ownership.
Proactive and problem-solving approach.
Ability to work with strict timelines.
Place of Posting: Zirakpur
Salary Negotiable
For immediate response please contact at
7889279470
9888226055
Schedule:
- Day shift
Ability to commute/relocate:
- Zirakpur, Punjab: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
**Speak with the employer**
+91 7889279470
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