Cliantha Research is currently seeking qualified candidates for the position of Regulatory Affairs Officer. This role is integral to the organization, focusing on the coordination and submission of regulatory documentation. Below is a detailed breakdown of the job responsibilities:
- Review and Finalization of Documentation: Collaborate with respective managers to review and finalize all documentation required by the Drugs Controller General of India (DCGI).
- Submission of Applications: Manage the submission process for BE-NOC (Bioequivalence No Objection Certificate) and T-license applications, ensuring adherence to DCGI guidelines.
- Query Management: Ensure timely response to any queries related to submitted applications in coordination with relevant team members.
- Regulatory Tracking: Monitor and track the status of regulatory approvals, updating a centralized common drive accessible to all locations.
- Record Maintenance: Maintain an up-to-date regulatory tracking sheet that logs submitted applications, approvals, and notifications.
Qualification Requirements
Cliantha Research is looking for candidates with the following qualifications:
- Education: A Bachelor’s degree in Pharmacy (B.Pharm) is mandatory.
- Knowledge: Basic understanding of regulatory processes and documentation associated with the pharmaceutical industry is required.
Note: Candidates with an M.Pharm or any higher qualification will not be considered for this role.
Key Skills and Attributes
To excel in the Regulatory Affairs Officer role at Cliantha Research, candidates should possess the following skills:
- Attention to Detail: A meticulous approach to documentation and compliance.
- Organizational Skills: Ability to manage multiple submissions and track approvals efficiently.
- Communication: Strong written and verbal communication skills for coordinating with managers and regulatory bodies.
- Proactivity: A proactive mindset to ensure timely submission of applications and response to queries.
- Team Collaboration: Ability to work cohesively with team members to meet regulatory deadlines.
How to Apply