Leben Life Sciences Hiring – Sr. Officer, Regulatory Affairs (Technical Document Reviewer)

Leben Life Sciences Pvt. Ltd. (LLS), a leading name in the pharmaceutical formulation industry with over four decades of experience, is expanding its team. With its EU-GMP Approved Global Standard OSD & Semi-Solids Formulation Manufacturing Facility in Akola, Maharashtra, the company is inviting applications for the role of Sr. Officer – Regulatory Affairs (Technical Document Reviewer).

If you are a pharmaceutical professional with 2–5 years of experience in document review, regulatory compliance, or QA/R&D, this is an excellent opportunity to join a reputed company committed to responsible healthcare.

Job Overview

Company: Leben Life Sciences Pvt. Ltd.
Industry: Pharmaceuticals (Formulations – OSD & Semi-Solids)
Position: Sr. Officer – Regulatory Affairs (Technical Document Reviewer)
Department: Regulatory Affairs (Formulation)
Experience Required: 2–5 years
Educational Qualification: B.Pharm / M.Pharm
Location: Akola, Maharashtra (M.S.)
Website: www.lebenlifesciences.com

Key Responsibilities

As a Sr. Officer in Regulatory Affairs, your role will involve ensuring compliance with international regulatory standards, document review, and lifecycle management of products. Below are the core responsibilities:

Document Review: Review and verify technical documents including Analytical Reports, CDPs, and product quality-related documentation.
Regulatory Compliance: Ensure consistency, accuracy, and compliance with ICH, EMA, USFDA, and WHO guidelines.
Cross-Verification: Cross-check analytical methods, Certificates of Analysis (COAs), validation reports, and related documents.
Team Coordination: Work closely with QA, QC, ADL, FDL, and Production teams to close documentation gaps and finalize reports.
Dossier Preparation: Support in preparation and review of dossiers (CTD/eCTD/ACTD/ROW) and regulatory submissions.
Lifecycle Management: Assist in lifecycle management of products – variations, renewals, and post-approval updates.
Audit Support: Maintain regulatory documentation and provide support during audits and inspections.

Qualification & Skills

Candidates must meet the following requirements to apply for this role:

Educational Qualification:
- Bachelor of Pharmacy (B.Pharm)
- Master of Pharmacy (M.Pharm)
Experience:
- 2–5 years of relevant experience in document review, regulatory affairs, QA, or R&D.
Key Skills:
- Strong knowledge of ICH, EMA, USFDA, and WHO guidelines.
- Excellent analytical and problem-solving skills.
- Proficiency in document management and regulatory submission processes.
- Effective communication and coordination skills for cross-departmental collaboration.

Salary Expectations

Although the job posting does not specify the exact salary, based on current industry standards for similar roles in the Indian pharmaceutical sector:

Sr. Officer (Regulatory Affairs): ₹5.0 – ₹8.5 LPA (depending on experience and expertise).

Additional compensation may include:

Provident Fund & Insurance coverage
Performance-based incentives
Professional development programs

Benefits of Working with Leben Life Sciences

Joining Leben Life Sciences Pvt. Ltd. offers multiple professional and personal benefits:

✅ Opportunity to work in a globally recognized, EU-GMP approved pharma company.
✅ Exposure to international regulatory frameworks including USFDA, EMA, WHO.
✅ Long-term career growth with a company having 40+ years of legacy.
✅ Collaborative work environment with skilled QA, QC, ADL, and FDL professionals.
✅ Job stability in a reputed pharmaceutical organization.

Application Process

Step 1 – Prepare Your Resume

Highlight relevant expertise in:

Document Review (Analytical/QA/R&D)
Regulatory submissions (CTD/eCTD/ACTD/ROW)
Knowledge of ICH/EMA/USFDA/WHO guidelines

Step 2 – Submit Your Application

📧 Email ID: [email protected]

📞 Contact Number: 7498035480

Step 3 – Shortlisting & Interview

Shortlisted candidates will be contacted via email/phone.
Interviews may include document review case studies, regulatory knowledge tests, and HR rounds.

About Leben Life Sciences Pvt. Ltd.

Leben Life Sciences Pvt. Ltd. (LLS) is a trusted pharmaceutical formulation company headquartered in Akola, Maharashtra. With a legacy of more than four decades, the company specializes in the manufacturing of Oral Solid Dosage (OSD) and Semi-Solid Formulations.

Key Highlights:

EU-GMP approved global standard manufacturing facility
Strong presence in domestic and international pharma markets
Commitment to Responsible Healthcare
Focus on compliance, quality, and patient-centric drug formulations

For more details, visit: www.lebenlifesciences.com

Conclusion

The Sr. Officer – Regulatory Affairs (Technical Document Reviewer) position at Leben Life Sciences Pvt. Ltd. is an excellent opportunity for pharmaceutical professionals with 2–5 years of experience in document review, QA, R&D, or regulatory affairs.

If you are passionate about regulatory compliance, technical documentation, and working in a globally certified pharma company, this is your chance to advance your career.

📢 Apply today by sending your resume to [email protected] and join a company that has been driving responsible healthcare for more than 40 years.