Leben Life Sciences Pvt. Ltd. is hiring experienced professionals for the role of Senior Officer – Technical Document Reviewer at its EU-GMP approved manufacturing facility in Akola, Maharashtra.
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This is an excellent opportunity for candidates with 2–3 years of experience in regulatory document review, CTD/eCTD dossier preparation, and pharmaceutical compliance. If you have a strong understanding of ICH, USFDA, EMA, and WHO guidelines, this role could be your next big career move.
Job Overview
- Company: Leben Life Sciences Pvt. Ltd.
- Department: Regulatory Affairs (Formulation)
- Position: Sr. Officer (Technical Document Reviewer)
- Location: Akola
- Experience: 2–3 Years
- Qualification: B.Pharm / M.Pharm
- Employment Type: Full-Time
Key Responsibilities
As a Regulatory Affairs Sr Officer, you will:
- Review and verify technical and analytical documents including CDPs and product quality data
- Ensure accuracy, consistency, and regulatory compliance across documentation
- Cross-check COAs, validation reports, and analytical methods
- Coordinate with QA, QC, ADL, FDL, and Production teams
- Prepare and review CTD, eCTD, ACTD, and ROW dossiers
- Support regulatory submissions, variations, and renewals
- Maintain documentation and assist in audits and inspections
Required Qualifications & Skills
- Education: B.Pharm / M.Pharm
- Experience: 2–3 years in Regulatory Affairs / QA / R&D document review
- Strong knowledge of:
- ICH Guidelines
- USFDA, EMA, WHO regulations
- Skills:
- Analytical thinking
- Documentation review expertise
- Communication & coordination
Why Join Leben Life Sciences?
- Work at an EU-GMP approved global standard facility
- Exposure to international regulatory markets (US/EU/ROW)
- Opportunity to build expertise in regulatory submissions and lifecycle management
- Collaborative environment with cross-functional teams
- Strong reputation with 40+ years in pharmaceutical manufacturing
Salary & Benefits
- Estimated Salary: ₹4.5 LPA – ₹7 LPA (based on experience)
- Performance-based growth opportunities
- Learning & development in global regulatory practices
- Stable and growth-oriented work environment
How to Apply
Interested candidates can apply using the details below:
📧 Email: career@lebenlifesciences.com
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