Job Overview
| Particulars | Details |
|---|---|
| Position | SR. OFFICER – ANALYTICAL DOCUMENTS REVIEWER |
| Company | Leben Life Sciences Pvt. Ltd. |
| Location | Akola, Maharashtra |
| Job Type | Full-Time |
| Experience | 2 - 3 years |
| Category / Department | Pharma |
| Application Mode |
🏢 About Leben Life Sciences Pvt. Ltd.
Leben Life Sciences Pvt. Ltd. (LLS) is an established pharmaceutical formulation company with over four decades of industry experience. The company operates a modern EU-GMP approved manufacturing facility specializing in Oral Solid Dosage (OSD) and semi-solid formulations in Akola, Maharashtra.
Known for its commitment to quality, innovation, and regulatory excellence, Leben Life Sciences continues to expand its global presence by delivering high-quality pharmaceutical products while maintaining the highest compliance standards.
⭐ Why Join Leben Life Sciences?
✅ Opportunity to work in an EU-GMP approved facility
✅ Exposure to global regulatory submission processes
✅ Professional growth and continuous learning opportunities
✅ Stable and collaborative work environment
✅ Competitive compensation and benefits
✅ Opportunity to work on international regulatory projects
Leben Life Sciences Pvt. Ltd.
Akola,
Maharashtra,
India
💡 Editor's Note / Preparation Tip
📄 Resume Tips
• Highlight your HPLC, QC, ADL, and regulatory affairs experience prominently.
• Include experience with CTD/eCTD dossier preparation and analytical documentation.
• Mention ICH guideline knowledge, method validation, stability studies, and impurity profiling expertise.
• Quantify achievements related to regulatory submissions, audits, or successful approvals.
• Include relevant certifications, trainings, and technical competencies.
🎯 Preparation Tips
• Review CTD/eCTD dossier structures and regulatory submission processes.
• Revise ICH guidelines (Q2, Q3, Q6, Q8, and Q9).
• Prepare to discuss HPLC operations, method validation, and stability studies.
• Review regulatory query handling and audit support procedures.
• Prepare examples of cross-functional collaboration and regulatory project experience.
💡 Pro Tips
• Research Leben Life Sciences' products, facilities, and regulatory presence.
• Demonstrate attention to detail and regulatory compliance awareness.
• Highlight your documentation and analytical review capabilities.
• Showcase examples of successful regulatory submissions or audits.
• Emphasize your ability to work collaboratively with QC, R&D, and regulatory teams.
📝 Job Description
🚀 WE'RE HIRING | SR. OFFICER – ANALYTICAL DOCUMENTS REVIEWER | REGULATORY AFFAIRS
Are you passionate about pharmaceutical regulatory affairs, analytical documentation, and global compliance standards? Join Leben Life Sciences Pvt. Ltd., a leading pharmaceutical formulation company with over four decades of excellence, and contribute to global regulatory submissions from its EU-GMP approved manufacturing facility.
📌 Position: Sr. Officer – Analytical Documents Reviewer
🏢 Department: Regulatory Affairs (Formulation)
📍 Location: Akola, Maharashtra
💼 Experience: 2–3 Years
🎓 Qualification: M.Sc. / M.Pharm / B.Pharm
🏭 Work Mode: On-site\
🎁 What We Offer
✅ Career growth in a reputed pharmaceutical organization
✅ Exposure to global regulatory standards and submissions
✅ Professional development opportunities
✅ Learning-focused work culture
✅ Long-term career stability
✅ Collaborative and quality-driven environment
📩 Apply Now: career@lebenlifesciences.com
Interested candidates can email their resume to career@lebenlifesciences.com. For more details, visit www.lebenlifesciences.com.
🎯 Key Responsibilities
- ✓ Prepare and review analytical sections of CTD/eCTD dossiers for global submissions.
- ✓ Review analytical method validation, method transfer, stability, and impurity data.
- ✓ Conduct gap assessments based on target market regulatory requirements.
- ✓ Coordinate with QC, ADL, R&D, and Stability departments.
- ✓ Prepare responses to regulatory authority queries.
- ✓ Support regulatory inspections and audits through analytical documentation.
- ✓ Track updates and changes in international regulatory guidelines.
- ✓ Ensure compliance with global regulatory standards and internal quality systems.
💡 Required Qualifications & Skills
Frequently Asked Questions
Q1. What experience is required for this role?
A: Candidates should have 2–3 years of relevant experience with mandatory hands-on HPLC experience.
Q2. Which educational qualifications are preferred?
A: M.Sc., M.Pharm, or B.Pharm in Pharmaceutical Analysis, Chemistry, or related disciplines.
Q3. Is prior regulatory affairs experience required?
A: Yes, experience in analytical documentation, dossier preparation, QC, or ADL is preferred.
Q4. What will be the primary responsibility?
A: Preparing and reviewing analytical sections of CTD/eCTD dossiers and supporting global regulatory submissions.
Q5. Is this a remote opportunity?
A: No, this is an on-site role based in Akola, Maharashtra.
Q6. What regulatory guidelines should candidates be familiar with?
A: Candidates should have strong knowledge of ICH guidelines, including Q2, Q3, Q6, Q8, and Q9.
Share This Job
🛡️ Safety Disclaimer: JobPortalConnect curates official listings for informational purposes. Genuine recruiters will never ask you for processing fees, training payments, or security deposits. If you spot suspicious activity, copyright issues, or wish to request the removal of this listing, please report it to us immediately at contact.jobportalconnect@gmail.com.