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Full Time

Senior Officer Analytical Documents Reviewer (Analyst)

Leben Life Sciences Pvt. Ltd.
Akola, Maharashtra, India
₹4 LPA - ₹5 LPA
Posted 03/08/2026

About the Role

Company Overview

Leben Life Sciences Pvt. Ltd. is a highly reputable pharma company. It has over four decades of experience in pharmaceutical manufacturing

There is a production facility in Akola that is approved as per EU-GMP guidelines. The company emphasizes regulatory compliance and innovation. The organization promotes a cooperative work environment along with the development of professional knowledge amongst the employees. Employees participate in various international regulatory projects.

Job Summary

The Senior Officer - Analytical Documents Reviewer (Analyst) is a job position within the Regulatory Affairs (Formulation) group. The position entails the review, compilation, and management of analytical documents necessary for regulatory submissions.

The incumbent will have the responsibility of ensuring the accuracy, completeness, and compliance of analytical data incorporated in CTD and eCTD dossiers. The position needs the individual to have skills in analytical methods especially HPLC. Knowledge about the regulatory guidelines is required. The individual should have an eye for details and be able to work in a cross-functional environment.

Key Responsibilities

The candidate will be responsible for preparation, review, and compilation of analytical sections of CTD and eCTD dossiers including:

  • Specifications

  • Analytical Method Validation (AMV) and

  • Certificates of Analysis (CoA)

The candidate will review analytical method validation reports, method transfer documents, stability data and impurity profiles. The candidate will make sure that all the analytical data is scientifically sound and well documented.

The role includes ensuring compliance with ICH guidelines such as:

  • Q2 (Analytical Validation)

  • Q3 (Impurities)

  • Q6 (Specifications)

  • Q8 (Pharmaceutical Development), and

  • Q9 (Quality Risk Management)

The candidate will stay updated with regulatory requirements for different global markets.

The person will work with various cross-functional teams such as QC, ADL, R&D, and Stability to gather and validate data.

The position requires the person to conduct an analysis of the gaps between the company’s analytical documentation and regulatory requirements for the target market as well as suggest the needed amendments. The person will prepare replies to the questions of regulatory authorities regarding documentation deficiencies.

The position entails preparation for the company's internal and external audits by providing analytical documentation.

Qualifications and Skill Requirement

Education-  B.Pharm or M.Pharm degree in Pharmaceutical Analysis, Chemistry, or a related discipline.

Experience- 2-3 years of hands-on experience with HPLC is mandatory.

The candidate must have experience working in QC or ADL settings.

The candidate must possess a thorough knowledge of analytical method validation, stability studies, and impurity analysis.

It is expected that the candidate should be aware of CTD and eCTD document formats.

Knowledge of ICH guidelines regarding analytical documents is very important.

The candidate must be an analytical thinker and possess good documentation skills.

Good communication and interpersonal skills are essential for coordinating within the team.

Salary and Benefits

Leben Life Sciences offers attractive remuneration based on experience and qualifications. The salary for this role is INR 4-5 LPA.

Working for this company provides employees with global exposure. Learning and development, on-the-job training, and career development opportunities are offered by the company. Health care packages, performance bonuses, and other perks provided by the company may be availed by the employees.

A supportive and developmental culture is emphasized within the organization.

Role Importance and Career Growth

It is very important to ensure that there is accurate analytical documentation in pharmaceutical submissions that complies with the regulations.

There is very good exposure to global regulations and analytical documentation in this role.

It contributes to building up skills in regulatory affairs and pharmaceutical analysis.

Some of the career development opportunities include Regulatory Affairs Officer, Senior Regulatory Specialist, or Analytical Lead.

Why Join Leben Life Sciences

Leben Life Sciences provides an opportunity for employees to work at a pharmaceutical company that has over 40 years of experience. The company offers the chance to be exposed to manufacturing according to EU GMP and submission of products in international markets.

The company offers employees a cooperative working environment that is conducive to learning new skills and gaining experience.

How To Apply

If this is the position you seek to apply for, you should apply through the following procedure:

  • Create your account in Jobslly.

  • Search for the position Senior Officer – Analytical Documents Reviewer/ Leben Life Sciences.

  • Upload your updated resume.

  • Upload all the related certificates.

  • Complete the application form.

Applicants should highlight their experience in analytical techniques, HPLC, and regulatory documentation.

Early application is recommended as positions may close once filled.

Market Insights & Trends

Salary Insights

The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.

Hiring Trends

The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.

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Frequently Asked Questions

Everything you need to know about the process

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Forget the assumption that only senior doctors make the big money. That's outdated. Right now, some of the best packages in Indian healthcare are going to people you wouldn't expect — Senior Medical Writers, Clinical Data Managers, Pharmacovigilance Specialists working with global pharma firms or CROs. These aren't rare unicorn jobs. They exist, they hire regularly, and the salaries are negotiable in ways hospital jobs rarely are. Most candidates just don't know to look for them.
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Both. That's the honest answer. Legitimate remote roles in healthcare have existed long before anyone started calling things "hybrid." Medical Coders, Pharmacovigilance Associates, Telehealth Coordinators, Freelance Medical Writers — these positions have been hiring remotely for years through companies that are very much real. The fake ones almost always have one thing in common: they ask for money. Registration fees, document processing charges, security deposits — whatever the label, it's a scam. No actual employer takes money from a candidate before they join. That rule holds without exception.
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Short answer: yes, and it's happening constantly. Long answer: it depends on what you want. If structured hours, no emergency calls, and a salary that doesn't plateau after three years sound appealing — corporate healthcare is worth your attention. Medical Writing, Drug Safety Review, Insurance Auditing, Health-tech Program Management — these roles specifically want people who understand clinical realities. A nursing degree or MBBS isn't a handicap here. It's often the reason you get the interview.