Lupin Limited’s biotechnology division. Lupin Biotech has announced a vacancy for the role of Executive – Regulatory Affairs at its Ghotawade, Pune facility, offering a strong career path for professionals experienced in biotech regulatory compliance, CTD dossier preparation, and licensing submissions.
This opportunity is ideal for candidates with 2–3 years of experience in biotech regulatory affairs who want exposure to global regulatory frameworks and advanced biotechnology manufacturing environments.
The opening reflects the growing demand for biotech regulatory affairs professionals in India, especially in companies expanding their biologics and biotechnology portfolios.
Job Overview
- Position: Executive – Regulatory Affairs
- Company: Lupin Biotech
- Location: Ghotawade, Pune, Maharashtra, India
- Experience: 2–3 years
- Education: Biotechnology / Biochemistry / Biopharmaceutics
- Industry: Biotechnology / Pharmaceutical Regulatory Affairs
This Lupin Biotech Regulatory Affairs job in Pune focuses on regulatory submissions, documentation, and compliance activities required for biotechnology products.
Key Responsibilities
Professionals applying for this biotech regulatory affairs job in India will be responsible for several critical regulatory functions:
- Preparing applications for various forms and licenses to CLAA and SLA
- Handling post-approval variations and regulatory query responses
- Compiling and submitting CTD/ACTD format regulatory dossiers
- Reviewing CMC-related documents from cross-functional teams
- Providing regulatory-compliant inputs to internal stakeholders
- Managing submissions through online regulatory portals
- Ensuring compliance with biotech regulatory requirements and guidelines
These responsibilities require a strong understanding of biotechnology regulatory frameworks and dossier preparation standards.
Required Qualifications
Candidates interested in this Regulatory Affairs Executive job at Lupin Biotech should meet the following requirements:
Education
- Postgraduate: Biotechnology or Biochemistry
- Undergraduate: Biotechnology or Biopharmaceutics
Experience
- 2–3 years of experience in a Biotech Regulatory Affairs department
Preferred Skills
- Experience in CTD / ACTD dossier preparation
- Knowledge of CLAA and SLA licensing processes
- Understanding of CMC documentation
- Familiarity with regulatory submission portals
- Strong documentation and regulatory compliance skills
Why Join Lupin Biotech?
Working with Lupin Biotech offers professionals exposure to one of India’s leading pharmaceutical and biotechnology ecosystems.
Key benefits include:
- Opportunity to work in a cutting-edge biotechnology environment
- Exposure to global regulatory frameworks and compliance systems
- Experience with advanced biologics regulatory submissions
- Collaborative and growth-driven workplace culture
- Career advancement in biotech regulatory affairs
For professionals targeting biotech regulatory affairs jobs in Pune, this role offers valuable industry exposure.
How to Apply
Interested candidates can apply by sending their updated resume to: