Regulatory Affairs Officer at Cliantha Research
Job Overview
| Job Title | Regulatory Affairs Officer |
|---|---|
| Company | Cliantha Research |
| Location | Ahmedabad, India |
| Experience Required | 0 – 2 years in Regulatory Affairs |
| Annual Salary | ₹1.75 – ₹3 Lakhs |
| Education Required | Bachelor’s Degree in Pharmacy (B.Pharm) |
| Application Mode | Online Application |
| Additional Notes | Only candidates with B.Pharm qualifications; M.Pharm or higher will not be considered. |
Regulatory Affairs Officer at Cliantha Research
About Cliantha Research
Cliantha Research is a leading clinical research organization (CRO) focused on advancing scientific research for the pharmaceutical and healthcare sectors. With a commitment to maintaining the highest regulatory standards, Cliantha offers robust solutions across drug development, regulatory compliance, and quality management. As a Regulatory Affairs Officer at Cliantha, you will play a key role in ensuring that all documentation and applications meet national regulatory standards. Regulatory Affairs Officer at Cliantha Research
Job Highlights
- Work/Life Balance: Emphasis on maintaining a balance between work responsibilities and personal life.
- Time Management: Encouragement to meet regulatory deadlines while managing priorities.
- Flexibility: Opportunity to work across a variety of regulatory tasks.
- Problem-Solving: Environment supportive of innovative approaches to regulatory challenges.
Regulatory Affairs Officer at Cliantha Research
Key Responsibilities
In this role, the Regulatory Affairs Officer will be responsible for the following:
- Documentation Review and Finalization: Work with managers to review and finalize all documentation required by the Drugs Controller General of India (DCGI).
- Submission Management: Handle the submission of BE-NOC (Bioequivalence No Objection Certificate) and T-license applications, ensuring strict adherence to DCGI guidelines.
- Query Handling: Address any queries related to submitted applications, collaborating with team members to ensure accurate responses.
- Regulatory Tracking: Monitor the progress of regulatory submissions and approvals, maintaining updates on a centralized common drive accessible across Cliantha locations.
- Record Maintenance: Keep an updated regulatory tracking sheet for all submitted applications, approvals, and notifications.
Regulatory Affairs Officer at Cliantha Research
Required Qualifications
- Education: A Bachelor’s degree in Pharmacy (B.Pharm) is mandatory.
- Knowledge: Basic understanding of regulatory processes within the pharmaceutical industry, especially concerning documentation and compliance.
- Note: Candidates with M.Pharm or higher qualifications are not eligible for this role.
Key Skills and Attributes
To succeed in the role, ideal candidates should possess:
- Attention to Detail: High accuracy in managing documentation and compliance requirements.
- Organizational Skills: Capability to manage multiple submissions efficiently, track approvals, and ensure timeliness.
- Communication: Strong written and verbal communication skills for collaborating with managers and regulatory bodies.
- Proactivity: Ability to anticipate and address regulatory needs and deadlines.
- Team Collaboration: Effective teamwork skills for coordination with multiple departments and ensuring regulatory deadlines are met.
Benefits of Working at Cliantha Research
- Professional Growth: Hands-on experience in regulatory affairs within a leading CRO.
- Collaborative Environment: Work with a skilled team dedicated to maintaining high standards in regulatory compliance.
- Learning Opportunities: Exposure to comprehensive training and development in regulatory processes.
Regulatory Affairs Officer at Cliantha Research
How to Apply
Interested candidates who meet the qualifications are encouraged to apply online. Please ensure that you meet the criteria of having a B.Pharm degree and a foundational understanding of regulatory documentation in the pharmaceutical sector.
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FAQs
1. What does the Regulatory Affairs Officer role entail?
- The position involves coordinating and submitting regulatory documentation in compliance with DCGI guidelines, managing the application process for BE-NOC and T-license, and maintaining accurate records.
2. What is the salary range for this position?
- The annual salary for this role ranges from ₹1.75 to ₹3 Lakhs.
3. Why should I consider a career with Cliantha Research?
- Cliantha Research offers a supportive work culture, opportunities for career growth, and the chance to work with a dedicated team in a leading clinical research organization.
This position at Cliantha Research presents an excellent opportunity for professionals starting their careers in regulatory affairs to gain valuable industry experience in a collaborative and detail-oriented environment. Apply now to join a team committed to regulatory excellence and contribute to impactful healthcare advancements.