"Leben Life Sciences Hiring Sr. Officer – Regulatory Affairs in Akola, Maharashtra"
Are you an experienced pharmaceutical professional seeking Regulatory Affairs jobs in India?
Leben Life Sciences Pvt. Ltd., a trusted pharmaceutical formulations company with over 40 years of excellence, is inviting applications for the role of Sr. Officer – Regulatory Affairs at its EU-GMP-certified manufacturing facility in Akola, Maharashtra.
This position offers a chance to contribute to global regulatory compliance, ensuring world-class pharmaceutical products meet stringent international standards. If you have 2–5 years of experience in regulatory document review and strong knowledge of global regulatory guidelines, this could be the next big step in your career.
Key Responsibilities:-
As a Sr. Officer in Regulatory Affairs at Leben Life Sciences, you will be responsible for:
- Reviewing and verifying technical documents such as Analytical Documents, CDPs, and product quality reports.
- Ensuring accuracy, compliance, and consistency in specifications, test methods, and analytical data.
- Cross-checking analytical methods, Certificates of Analysis (COAs), and validation reports.
- Coordinating with QA, QC, ADL, FDL, and Production teams to close documentation gaps.
- Supporting preparation and review of regulatory dossiers (CTD/eCTD/ACTD/ROW) for international submissions.
- Assisting in lifecycle management, including variations, renewals, and post-approval updates.
- Maintaining regulatory records and assisting during audits and inspections.
Required Qualifications & Skills:-
To qualify for this Regulatory Affairs job in India, you should have:
- Education: B.Pharm or M.Pharm degree.
- Experience: 2–5 years in regulatory affairs, analytical QA, or R&D document review.
- Knowledge: Strong understanding of ICH, EMA, USFDA, and WHO guidelines.
- Skills: Excellent analytical, documentation, and communication skills.
- Preferred: Hands-on experience with dossier preparation (CTD/eCTD) and global submissions.
Benefits of Joining Leben Life Sciences:-
By joining Leben Life Sciences, you’ll gain:
- Career Growth: Opportunities in a globally recognized EU-GMP-approved facility.
- Cross-Functional Learning: Work with QA, QC, and Production teams.
- Global Exposure: Contribute to pharmaceutical products distributed worldwide.
- Supportive Culture: Be part of a company with four decades of trust and innovation.
How to Apply:-
Interested candidates can apply through the following:
📅 Last date to apply: September 30, 2025
Frequently Asked Questions (FAQs):-
Q1: What does a Sr. Officer in Regulatory Affairs do at Leben Life Sciences?
A: The Sr. Officer reviews pharmaceutical documents, ensures compliance with regulatory guidelines, supports dossier preparation, and collaborates with QA, QC, and Production teams.
Q2: What qualifications are required for this role?
A: Applicants must hold a B.Pharm or M.Pharm degree with 2–5 years of experience in regulatory affairs or document review, along with knowledge of ICH, EMA, and USFDA guidelines.
Q3: Where is this job located?
A: The position is based at Leben Life Sciences’ EU-GMP-approved facility in Akola, Maharashtra.
👉 This is a great opportunity for pharma professionals aiming to build a rewarding career in Regulatory Affairs in India with global exposure.
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