Leben Hiring Regulatory Affairs

Regulatory Affairs Pharma Jobs Alert – BPharm MPharm Professionals Hiring in Akola with Global Exposure

Leben Life Sciences Pvt. Ltd. is actively hiring for the Regulatory Affairs (Formulation) department, offering an excellent opportunity for candidates with 2–3 years of experience to step into a high-impact role as Sr. Officer – Technical Document Reviewer. This opening is based at the company’s EU-GMP approved OSD and semi-solids manufacturing facility in Akola, Maharashtra. Candidates with B.Pharm or M.Pharm qualifications and experience in regulatory documentation, QA, or R&D are strongly encouraged to apply.

This role is particularly valuable for professionals aiming to grow in regulatory affairs, dossier preparation, and pharmaceutical compliance careers. It provides direct exposure to global regulatory standards and documentation practices aligned with ICH, USFDA, EMA, and WHO guidelines.

Company Overview

Leben Life Sciences Pvt. Ltd. is a well-established pharmaceutical formulation company with over four decades of industry presence. The company is known for its strong focus on quality manufacturing, regulatory compliance, and global market reach.

Its Akola facility is EU-GMP approved and designed to meet international standards for oral solid dosage (OSD) and semi-solid formulations. Leben supplies pharmaceutical products to multiple global markets, making it a trusted name in regulated and semi-regulated regions.

Working at Leben Life Sciences offers professionals exposure to:

• Global regulatory submission frameworks (CTD, eCTD, ACTD)
• Pharmaceutical formulation and development processes
• Quality systems aligned with international guidelines
• Cross-functional collaboration across QA, QC, R&D, and production

This environment is ideal for candidates aiming to build long-term careers in regulatory affairs and pharmaceutical compliance.

Job Role & Responsibilities

Sr. Officer – Technical Document Reviewer (Regulatory Affairs)

This role focuses on reviewing and ensuring the accuracy of critical pharmaceutical documentation required for regulatory submissions and compliance.

Key responsibilities include:

• Review and verify analytical and technical documents including CDPs and product quality records
• Ensure consistency and compliance across specifications, test methods, and reports
• Cross-check analytical methods, COAs, validation reports, and supporting documentation
• Coordinate with QA, QC, ADL, FDL, and Production teams to resolve documentation gaps
• Support preparation and review of dossiers (CTD, eCTD, ACTD, ROW submissions)
• Assist in lifecycle management activities including variations, renewals, and post-approval updates
• Maintain regulatory documentation and support during audits and inspections

This role directly contributes to ensuring that pharmaceutical products meet global regulatory standards and reach international markets efficiently.

Eligibility / Qualifications

Required Education

Candidates must have a pharmaceutical background.

Accepted courses include:

B.Pharm, M.Pharm, Pharmaceutical Sciences

Experience Requirements

• 2 to 3 years of experience in document review, regulatory affairs, QA, or R&D
• Strong understanding of regulatory guidelines such as ICH, EMA, USFDA, WHO
• Good analytical, communication, and coordination skills

Candidates with experience in dossier preparation and technical documentation will have an added advantage.

Location & Salary

Location:

• Akola, Maharashtra

Salary:

• Salary is not disclosed
• Regulatory affairs roles typically offer strong salary growth, especially with global submission experience and compliance expertise

Application Process

Interested candidates can apply by sending their resume via email:

career@lebenlifesciences.com

Contact: 7498035480

Candidates should ensure their resume highlights:

• Experience in regulatory documentation or QA/R&D
• Knowledge of CTD/eCTD submissions
• Familiarity with global regulatory guidelines

Why This Opportunity Stands Out

• Work in an EU-GMP approved global standard facility
• Direct exposure to international regulatory submissions
• Strong career growth in regulatory affairs and pharma compliance
• Opportunity to collaborate with multiple pharma departments

This role is ideal for professionals aiming to advance in regulatory affairs, pharmaceutical documentation, and global compliance functions.

FAQs

What does a Technical Document Reviewer do in pharma?

This role involves reviewing and validating technical and analytical documents to ensure regulatory compliance before submission.

Is this role suitable for B.Pharm candidates?

Yes, both B.Pharm and M.Pharm candidates with relevant experience are eligible.

What is the career scope in regulatory affairs?

Regulatory affairs offers strong global career opportunities with high salary growth and exposure to international markets.

What experience is required?

Candidates should have 2–3 years of experience in regulatory affairs, QA, or R&D documentation.

How to apply?

Candidates can apply by sending their resume to the provided email ID.

Summary Table

Company	Leben Life Sciences Pvt. Ltd.
Vacancies	Sr. Officer – Technical Document Reviewer (Regulatory Affairs)
Required Education	B.Pharm, M.Pharm, Pharmaceutical Sciences
Experience	2–3 years in Regulatory Affairs / QA / R&D