Position: Asst. Manager-DRA
Qualification: Bachelor's degree in Life Sciences, Pharmacy, or a related technical field; a master's degree or RA certification is a plus.
Expr:5-8 years in DRA
Job Description:
- Identifying the most efficient regulatory pathway for drug approval.
- Preparing a comprehensive plan to comply with international regulatory requirements.
- Advising on timelines, documentation, and submission requirements.
- Investigational New Drug (IND) Applications: For clinical trials.
- New Drug Applications (NDA): To obtain market approval.
- Abbreviated New Drug Applications (ANDA): For generic drug approvals.
- Biologics License Applications (BLA): For biologics and biosimilars.
- Responding to queries and requests for additional information.
- Attending meetings with regulatory agencies to discuss the drug development process.
- Ensuring compliance with post-approval changes and modifications.
- Conducting periodic audits and inspections.
- Managing post-market surveillance activities.
- Reviewing and submitting periodic safety update reports (PSURs).
- Ensuring compliance with pharmacovigilance and adverse event reporting.
- Managing Regulatory Intelligence
- Labeling and Advertising Compliance
- Risk Management and Mitigation
Pls share ur resume:[email protected]
Call us: 7827931592
Pay: ₹500,000.00 - ₹600,000.00 per year
Benefits:
- Health insurance
- Provident Fund
Work Location: In person
