Leben Life Sciences Hiring Freshers for Regulatory Affairs Trainee Akola with training, growth opportunities, and global regulatory exposure.
Leben Life Sciences Pvt. Ltd., a well-established pharmaceutical manufacturing organization with more than four decades of industry expertise, has announced openings for the role of Regulatory Affairs Trainee at its state-of-the-art facility in Akola, Maharashtra. This opportunity is ideal for fresh M.Pharm graduates who aspire to build a career in regulatory affairs and contribute to the development and documentation of global pharmaceutical products. The company operates an EU-GMP approved manufacturing plant specializing in oral solid dosage (OSD) and semi-solid formulations, making it a strong training ground for young regulatory professionals. Leben Life Sciences Hiring Freshers for Regulatory Affairs Trainee
Regulatory Affairs is one of the most dynamic and rapidly expanding career domains in the pharmaceutical industry. It involves ensuring that pharmaceutical products comply with all global regulatory guidelines and policies throughout their lifecycle. Fresh graduates entering this field gain exposure to international regulatory standards, dossier preparation, submission processes, audit readiness, and lifecycle management of pharmaceutical products. Leben Life Sciences is offering exactly this type of hands-on industry experience through its trainee program. Leben Life Sciences Hiring Freshers for Regulatory Affairs Trainee
This long-format article covers the job role, eligibility criteria, responsibilities, work culture, benefits, and application process, helping fresh candidates understand what to expect and how to apply effectively. Leben Life Sciences Hiring Freshers for Regulatory Affairs Trainee
About Leben Life Sciences Pvt. Ltd.
Leben Life Sciences is a reputable pharmaceutical company known for its commitment to quality, innovation, and compliance. With over 40 years of experience, the organization has been consistently delivering high-quality formulations to domestic and international markets. The company’s manufacturing facility in Akola, Maharashtra, is EU-GMP certified, ensuring that its operations adhere to the strictest global quality and safety standards. Leben Life Sciences Hiring Freshers for Regulatory Affairs Trainee
Leben specializes in OSD and semi-solid formulations, following guidelines mandated by major international regulatory authorities. With a strong focus on research, documentation, and quality compliance, the company has built a reputation for producing reliable pharmaceutical products for multiple regulatory markets.
Working at Leben offers young professionals the opportunity to learn regulatory practices in a real-world manufacturing environment and become industry-ready for advanced regulatory roles. Leben Life Sciences Hiring Freshers for Regulatory Affairs Trainee
Job Overview: Regulatory Affairs Trainee
Position Title: Regulatory Affairs Trainee
Company: Leben Life Sciences Pvt. Ltd.
Location: Akola, Maharashtra
Eligibility: M.Pharm graduates
Experience: 0–1 year (Freshers welcome)
Preferred Candidates: Male candidates, as specified by the organization
Job Mode: Full-time
Application Mode: Email application
This position is specifically designed for fresh M.Pharm graduates who want to develop a career in regulatory documentation, compliance, and dossier preparation. The role involves working closely with key pharmaceutical teams including QA, QC, Documentation, and Manufacturing to ensure product compliance across global markets. Leben Life Sciences Hiring Freshers for Regulatory Affairs Trainee
Responsibilities of a Regulatory Affairs Trainee
The Regulatory Affairs Trainee role at Leben Life Sciences involves a structured set of responsibilities designed to build strong regulatory foundations in fresh graduates. Trainees will work under the guidance of experienced regulatory professionals and will gain exposure to global documentation and product registration processes. Leben Life Sciences Hiring Freshers for Regulatory Affairs Trainee
1. Preparation, Review, and Submission of Regulatory Documents
Trainees assist in the preparation of essential regulatory documents required for product approvals. This includes reviewing documents for accuracy, completeness, and compliance with regulatory requirements before submission.
2. Supporting Regulatory Compliance Activities
Regulatory compliance is mandatory throughout the product lifecycle. Trainees support activities that ensure compliance during product development, manufacturing, packaging, and distribution.
3. Coordination with Manufacturing, QA, QC, and Documentation Departments
Since regulatory affairs is a cross-functional domain, the trainee must coordinate closely with other teams. This includes collecting necessary documents, reviewing batch records, obtaining technical inputs, and ensuring alignment across departments.
4. Maintaining Regulatory Databases and Tracking Submissions
Accurate documentation and tracking of regulatory submissions are crucial. Trainees will maintain internal databases, update submission trackers, and assist in organizing regulatory files for audits and internal reviews.
5. Ensuring Adherence to International Regulatory Guidelines
Pharmaceutical companies must follow guidelines set by regulatory authorities such as EU, US, MHRA, WHO, and others. Trainees are expected to understand and implement these regulatory expectations while preparing documents.
6. Preparing Product Dossiers for Multiple Markets
One of the key responsibilities is assisting in the preparation of product dossiers, which include quality, safety, and efficacy data. These dossiers are required for product registration across various global markets.
7. Supporting Audit Readiness Activities
Trainees help in preparing for regulatory audits by ensuring that documents are organized, updated, and compliant. This includes assisting in mock audits and addressing documentation gaps.
Eligibility Criteria
Candidates must meet the following eligibility requirements to apply for the Regulatory Affairs Trainee position: Leben Life Sciences Hiring Freshers for Regulatory Affairs Trainee
Educational Qualification
- M.Pharm is mandatory for this role
- Candidates from Pharmaceutics or Pharmaceutical Quality backgrounds are particularly suitable
Experience Requirement
- 0–1 year of experience
- Freshers are encouraged to apply
Preferred Profile
- Male candidates as per company preference
- Strong communication, analytical, and documentation skills
- Basic understanding of pharmaceutical regulatory systems
- Interest in learning dossier preparation and international documentation standards
- Ability to work collaboratively with multi-disciplinary teams
Why Choose a Regulatory Affairs Career at Leben Life Sciences?
Leben Life Sciences offers an excellent platform for pharmacy graduates to begin their journey in the regulatory sector. Freshers receive structured training, practical exposure, and the opportunity to work in an internationally certified facility. Leben Life Sciences Hiring Freshers for Regulatory Affairs Trainee
1. Exposure to EU-GMP Approved Facility
Working in an EU-GMP certified environment offers real-time exposure to global quality and compliance standards that shape the core of regulatory affairs.
2. Learning OSD and Semi-Solid Formulation Documentation
Trainees gain hands-on experience in reviewing and preparing documentation for tablets, capsules, creams, and ointments.
3. Training in International Regulatory Markets
Candidates learn documentation techniques relevant to global markets such as Europe, Asia-Pacific, Latin America, and Africa.
4. Professional Career Growth Opportunities
Regulatory affairs professionals are in high demand, and trained freshers often move into roles such as: Leben Life Sciences Hiring Freshers for Regulatory Affairs Trainee
- Regulatory Officer
- Dossier Specialist
- Regulatory Associate
- Compliance Analyst
- Quality Documentation Specialist
5. Supportive Learning Environment
The organization offers a supportive training setup, guidance from experienced regulatory professionals, and a structured development program. Leben Life Sciences Hiring Freshers for Regulatory Affairs Trainee
Job Location
Location: Akola, Maharashtra
Facility Type: EU-GMP approved OSD and Semi-Solid manufacturing plant
Candidates applying should be ready to relocate to Akola if selected.
How to Apply
Interested and eligible candidates can submit their resume through the official recruitment email provided by Leben Life Sciences. Leben Life Sciences Hiring Freshers for Regulatory Affairs Trainee
Email for Application:
Contact for Queries:
7498035480
While sending the application email, ensure you include:
- Updated resume
- Contact number
- Educational qualification
- Current location
- Expected joining date
For verified pharma job updates, visit PharmaJobHub.in – India’s trusted pharma career portal.
Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
