Leben Life Sciences Hiring Sr. Officer Regulatory Affairs

Leben Life Sciences pvt ltd

Maharashtra

On-site

INR 600,000 - 900,000

Full time

14 days+

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Job summary

Leben Life Sciences Pvt. Ltd. in Akola, Maharashtra, invites a Senior Officer – Regulatory Affairs (Formulation) to join its EU-GMP compliant facility.

You will lead technical document review, ensure regulatory compliance, and support CTD/eCTD dossiers across global markets, working closely with QA, QC, R&D, and manufacturing teams. The role requires B.Pharm or M.Pharm and 2–3 years of regulatory or technical documentation experience, with strong knowledge of ICH, EMA, USFDA, and WHO guidelines.

Qualifications

Strong knowledge of ICH, EMA, USFDA, and WHO regulatory guidelines.
Understanding of CTD/eCTD dossier structures and regulatory expectations.
Excellent analytical, communication, and cross-functional coordination skills.
High attention to detail and documentation accuracy.

Responsibilities

Reviewing and verifying technical documents including analytical documents, CDPs, and product quality records
Ensuring compliance, accuracy, and consistency across specifications, test methods, and analytical reports
Cross-checking analytical methods, Certificates of Analysis (COAs), validation reports, and related documentation
Coordinating with QA, QC, Analytical Development Laboratory (ADL), Formulation Development Laboratory (FDL), and Production teams to close documentation gaps
Supporting preparation and review of regulatory dossiers such as CTD, eCTD, ACTD, and ROW submissions
Assisting in product lifecycle management activities including variations, renewals, and post-approval changes
Maintaining regulatory documentation systems and supporting audits and regulatory inspections

Skills

Regulatory guidelines ICH EMA USFDAWHO

CTD/eCTD dossier knowledge

Technical document Review

Analytical skills

Cross-functional coordination

Communication skills

Attention to detail

Education

B.Pharm

M.Pharm

Job description

M.Pharm Regulatory Affairs Jobs at Leben Akola

Leben Life Sciences hiring Sr. Officer Regulatory Affairs in Akola. B.Pharm, M.Pharm eligible. 2–3 years experience required.

Leben Life Sciences Pvt. Ltd. (LLS), a trusted pharmaceutical formulation company with more than four decades of industry excellence, is hiring experienced Regulatory Affairs professionals for its EU-GMP approved global standard manufacturing facility at Akola, Maharashtra. This opening is designed for candidates with strong technical documentation and regulatory review expertise who want to work closely with quality, R&D, and manufacturing teams supporting regulated markets.

This role offers direct exposure to global regulatory submissions, product lifecycle management, and audit-facing documentation in a compliance-driven pharmaceutical environment.

Company Overview

Leben Life Sciences Pvt. Ltd. is a well-established pharmaceutical formulation company with over 40 years of manufacturing and regulatory experience. The company operates EU-GMP approved facilities for Oral Solid Dosage (OSD) and Semi-Solid formulations, supplying high-quality medicines to domestic and international markets.

LLS is known for its robust quality systems, regulatory compliance culture, and commitment to patient safety. Its operations align with global regulatory standards including USFDA, EMA, WHO, and ICH guidelines. Professionals at Leben Life Sciences work in structured, audit-ready environments that emphasize accuracy, consistency, and continuous improvement.

Joining Leben Life Sciences provides regulatory professionals long-term career stability, global exposure, and opportunities to contribute to responsible healthcare manufacturing.

Job Role & Responsibilities

Leben Life Sciences is hiring for the position of Senior Officer – Regulatory Affairs (Formulation). This role focuses on technical document review, regulatory compliance, and dossier support activities.

Senior Officer – Regulatory Affairs (Technical Document Reviewer)

Experience: 2 to 3 Years

Key Responsibilities

Reviewing and verifying technical documents including analytical documents, CDPs, and product quality records
Ensuring compliance, accuracy, and consistency across specifications, test methods, and analytical reports
Cross-checking analytical methods, Certificates of Analysis (COAs), validation reports, and related documentation
Coordinating with QA, QC, Analytical Development Laboratory (ADL), Formulation Development Laboratory (FDL), and Production teams to close documentation gaps
Supporting preparation and review of regulatory dossiers such as CTD, eCTD, ACTD, and ROW submissions
Assisting in product lifecycle management activities including variations, renewals, and post-approval changes
Maintaining regulatory documentation systems and supporting audits and regulatory inspections

This role plays a critical part in ensuring dossier accuracy, regulatory acceptance, and timely approvals across global markets.

Eligibility / Qualifications

Required Education

B.Pharm, M.Pharm

Required Experience

2 to 3 years of experience in document review within Regulatory Affairs, AQA, or R&D functions
Hands-on exposure to technical documentation review and regulatory compliance activities

Required Skills

Strong knowledge of ICH, EMA, USFDA, and WHO regulatory guidelines
Understanding of CTD/eCTD dossier structures and regulatory expectations
Excellent analytical, communication, and cross-functional coordination skills
High attention to detail and documentation accuracy

Location & Salary

Work Location: Akola, Maharashtra

Salary:
Compensation will be competitive and aligned with industry standards for regulatory affairs professionals. Salary will depend on experience, qualification, and regulatory exposure and will be discussed during the interview process.

Why Build a Career in Regulatory Affairs at Leben Life Sciences

Regulatory Affairs roles are among the highest CPC job categories in the pharmaceutical industry due to their direct impact on product approvals and global compliance. Search terms such as regulatory affairs jobs in pharma, CTD eCTD dossier jobs, and formulation regulatory careers attract strong advertiser demand.

At Leben Life Sciences, professionals gain hands-on exposure to EU-GMP manufacturing, global dossier submissions, and lifecycle management activities that strengthen long-term career prospects.

Frequently Asked Questions (FAQs)

Who can apply for this Regulatory Affairs role?

Candidates with B.Pharm or M.Pharm qualifications and 2–3 years of regulatory or technical document review experience are eligible.

Is dossier experience mandatory?

Yes. Exposure to CTD, eCTD, ACTD, or ROW dossiers is required for this role.

Where is the job location?

The job location is Akola, Maharashtra.

Is this a manufacturing or office-based role?

This is a regulatory documentation and coordination role closely linked with manufacturing, quality, and R&D teams.

Career Growth at Leben Life Sciences

Regulatory Affairs professionals with formulation and dossier exposure can progress into senior regulatory, regulatory strategy, and global submission roles. Experience in EU-GMP environments significantly enhances global career mobility.

By joining Leben Life Sciences, candidates contribute directly to compliant product approvals and responsible healthcare delivery.

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