COD Research is a reputed organization in the pharmaceutical and regulatory affairs domain, known for its expertise in compliance, drug submissions, and regulatory documentation. The company assists in global regulatory approvals and maintains high standards in pharmacovigilance and quality assurance.
(Note: For more details, visit PharmaBharat.com, a platform dedicated to pharmaceutical jobs and industry updates.)
Job Description
Key Responsibilities:
✔ Write, analyze, and edit technical documents for regulatory submissions (eCTD, CTD, country-specific filings).
✔ Compile regulatory submissions in compliance with guidelines (USFDA, EMA, etc.).
✔ Coordinate with cross-functional teams for document collection and submission requirements.
✔ Maintain regulatory files, renewals, and updates for product approvals.
✔ Assist in Annual Report Writing for USFDA and Product Transfer documentation.
✔ Review product labels and promotional materials for regulatory compliance.
✔ Support regulatory audits and respond to authority queries within deadlines.
✔ Stay updated with changing regulatory policies and industry trends.
Qualifications & Experience Required:
- B.Pharm / M.Pharm or Life Sciences Graduate.
- 0-2 years of experience in Regulatory Affairs (Freshers with strong knowledge may apply).
- Knowledge of eCTD compilation, USFDA submissions, and ICH guidelines.
- Strong technical writing and documentation skills.
- Immediate joiners will be given preference.
How to Apply?
