Are you a skilled pharmaceutical professional with a passion for regulatory affairs? Leben Life Sciences Pvt. Ltd., a trusted name in pharmaceutical formulations for over 40 years, is hiring a Sr. Officer in Regulatory Affairs for its EU-GMP-approved manufacturing facility in Akola, Maharashtra. This role offers an exciting opportunity to contribute to global regulatory compliance, ensuring high-quality pharmaceutical products reach markets worldwide. If you have 2-5 years of experience in regulatory document review and a strong understanding of ICH, EMA, and USFDA guidelines, this Regulatory Affairs job in India could be your next career move!
Key Responsibilities
As a Sr. Officer in Regulatory Affairs, you will play a critical role in ensuring compliance and quality in pharmaceutical documentation. Your responsibilities will include:
- Reviewing and verifying technical documents, including Analytical Documents, CDPs, and product quality reports.
- Ensuring accuracy, compliance, and consistency in specifications, test methods, and analytical reports.
- Cross-checking analytical methods, Certificates of Analysis (COAs), and validation reports.
- Collaborating with QA, QC, ADL, FDL, and Production teams to address documentation gaps.
- Supporting the preparation and review of regulatory dossiers (CTD/eCTD/ACTD/ROW) for global submissions.
- Assisting in lifecycle management, including product variations, renewals, and post-approval updates.
- Maintaining regulatory documentation and supporting audits and inspections.
Qualifications and Skills
To excel in this pharmaceutical regulatory affairs job, candidates must meet the following requirements:
- Education: B.Pharm or M.Pharm from a recognized institution.
- Experience: 2-5 years in regulatory affairs, analytical quality assurance (AQA), or R&D document review.
- Technical Knowledge: Strong understanding of ICH, EMA, USFDA, and WHO guidelines.
- Skills: Excellent analytical, communication, and coordination skills to work across departments.
- Preferred: Experience with dossier preparation (CTD/eCTD) and regulatory submissions.
Benefits
Joining Leben Life Sciences offers a range of benefits, including:
- Career Growth: Work in a globally recognized, EU-GMP-approved facility with opportunities for professional development.
- Collaborative Environment: Engage with cross-functional teams in QA, QC, and production.
- Impactful Work: Contribute to high-quality pharmaceutical products for global markets.
- Supportive Culture: Be part of a company with over four decades of pharmaceutical expertise.
Application Instructions
Ready to take the next step in your regulatory affairs career? Interested candidates can:
- Email their resume to: career@lebenlifesciences.com
- WhatsApp their resume to: +91 7498035480
- Visit www.lebenlifesciences.com for more details about the company and role.
Ensure your application highlights your experience in regulatory affairs and document review. Applications are accepted until September 30, 2025.
Frequently Asked Questions (FAQs)
Q: What is the role of a Sr. Officer in Regulatory Affairs at Leben Life Sciences?
A: The Sr. Officer reviews technical documents, ensures regulatory compliance, and supports dossier preparation for global submissions, collaborating with QA, QC, and production teams.
Q: What qualifications are required for this Regulatory Affairs job?
A: Candidates need a B.Pharm or M.Pharm degree and 2-5 years of experience in regulatory affairs or document review, with knowledge of ICH, EMA, and USFDA guidelines.
