Regulatory Affairs Job at Lupin Biotech in Pune. Biotechnology and biochemistry candidates with 2–3 years experience can apply.
Company Overview
Lupin Limited is one of India’s leading pharmaceutical and biotechnology companies with a strong global presence in the development, manufacturing, and marketing of pharmaceutical and biotechnology products. The company is known for its focus on innovation, quality manufacturing, and compliance with international regulatory standards.
The biotechnology division of Lupin, Lupin Biotech, focuses on the development and manufacturing of advanced biologics and biotechnology-based pharmaceutical products. With cutting-edge research facilities and advanced manufacturing infrastructure, Lupin Biotech provides professionals with the opportunity to work in a highly regulated and technologically advanced environment.
Lupin Biotech has announced an opening for the position of Executive – Regulatory Affairs at its Ghotawade facility in Pune, Maharashtra. This role is ideal for professionals with experience in biotechnology regulatory affairs, regulatory documentation, and dossier preparation. Regulatory Affairs Job at Lupin Biotech
Job Overview
| Job Title | Executive – Regulatory Affairs |
|---|---|
| Company | Lupin Biotech (Lupin Limited) |
| Department | Regulatory Affairs |
| Job Location | Ghotawade, Pune, Maharashtra |
| Employment Type | Full-Time |
| Experience Required | 2 – 3 Years |
| Qualification | Biotechnology / Biochemistry / Biopharmaceutics |
| Industry | Biotechnology / Pharmaceutical Regulatory Affairs |
| Application Mode | Email Application |
Job Location & Employment Type
The selected candidate will work at Lupin Biotech’s Ghotawade facility located in Pune, Maharashtra. This facility is part of Lupin’s biotechnology manufacturing and development network and focuses on the production and regulatory management of biologic pharmaceutical products.
The position is a full-time role within the Regulatory Affairs department. The selected professional will work closely with cross-functional teams to manage regulatory submissions, compliance activities, and documentation for biotechnology products. Regulatory Affairs Job at Lupin Biotech
Open Position / Department Details
Executive – Regulatory Affairs
The Executive – Regulatory Affairs will support regulatory submission and compliance activities related to biotechnology products. The role involves preparing regulatory documentation, coordinating with internal teams, and ensuring that biotechnology products comply with regulatory requirements.
Professionals in this position will contribute to regulatory submissions, licensing documentation, and lifecycle management activities while ensuring adherence to regulatory standards. Regulatory Affairs Job at Lupin Biotech
Key Roles & Responsibilities
Candidates selected for this role will handle various regulatory affairs activities related to biotechnology product submissions and compliance.
Key responsibilities include:
- Preparing applications for various regulatory forms and licenses required by CLAA (Central License Approving Authority) and State Licensing Authority (SLA)
- Managing post-approval variations and responding to regulatory queries
- Compiling and submitting regulatory dossiers in CTD (Common Technical Document) and ACTD formats
- Reviewing Chemistry, Manufacturing, and Controls (CMC) documentation received from cross-functional teams
- Providing regulatory guidance and compliance-related inputs to internal departments
- Managing regulatory submissions through online regulatory submission portals
- Ensuring compliance with biotechnology regulatory requirements and industry guidelines
- Coordinating with regulatory authorities and internal stakeholders during submission processes
- Maintaining accurate documentation related to regulatory submissions and approvals
Eligibility Criteria
Candidates interested in applying for this position must meet the following eligibility requirements. Regulatory Affairs Job at Lupin Biotech
Education
Applicants should possess one of the following qualifications:
Postgraduate Degree
- Biotechnology
- Biochemistry
Undergraduate Degree
- Biotechnology
- Biopharmaceutics
Candidates with academic backgrounds related to biotechnology and pharmaceutical sciences are preferred.
Experience
- Minimum 2 to 3 years of experience in Biotechnology Regulatory Affairs
- Experience working in pharmaceutical or biotechnology regulatory departments is required
Skills Required
Candidates applying for this role should ideally have:
- Experience in CTD / ACTD dossier preparation
- Knowledge of regulatory licensing processes involving CLAA and SLA authorities
- Understanding of CMC documentation and regulatory submission requirements
- Familiarity with regulatory submission portals and electronic submission systems
- Strong documentation and regulatory compliance management skills
- Ability to coordinate with cross-functional teams and regulatory authorities
- Good analytical and communication skills
Salary & Benefits
Compensation for this role will be as per company norms, depending on the candidate’s qualifications, professional experience, and technical expertise. Regulatory Affairs Job at Lupin Biotech
Additional Benefits
Employees working with Lupin Biotech may receive:
- Opportunity to work in a leading biotechnology and pharmaceutical company
- Exposure to international regulatory frameworks and submission processes
- Experience working with advanced biotechnology products and biologics
- Collaborative and professional work environment
- Long-term career development opportunities in biotechnology regulatory affairs
Selection Process
The recruitment process for this position will typically involve the following steps:
- Resume screening and shortlisting
- HR discussion with shortlisted candidates
- Technical interview focusing on regulatory affairs expertise
- Final selection based on experience, qualifications, and regulatory knowledge
Candidates who meet the job requirements and perform well during the interview process may receive further communication regarding the next steps.
How to Apply
Interested candidates who meet the eligibility criteria can apply by sending their updated resume via email.
Email Application
Candidates should send their CV to:
Applicants are encouraged to include detailed information about their regulatory affairs experience, dossier preparation skills, and biotechnology regulatory exposure in their resume. Regulatory Affairs Job at Lupin Biotech
Important Dates
| Event | Date |
|---|---|
| Application Mode | Email Application |
Candidates are advised to submit their applications as early as possible.
Why Apply for This Pharma Job?
This opportunity at Lupin Biotech provides professionals with the chance to work in a rapidly growing biotechnology sector within one of India’s leading pharmaceutical companies. The role offers valuable exposure to biotechnology regulatory frameworks, global compliance systems, and regulatory submission processes.
Working in Lupin’s biotechnology division allows professionals to gain experience with advanced biologics and biotechnology products, which are among the fastest-growing segments of the pharmaceutical industry. Regulatory Affairs Job at Lupin Biotech
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical and life sciences job opportunities for informational purposes only. We are not affiliated with Lupin Limited or any organization mentioned in this post.
Applicants are advised to verify job details directly with the company before submitting applications or sharing personal information. Regulatory Affairs Job at Lupin Biotech
Final Call-to-Action
Professionals with experience in biotechnology regulatory affairs who are interested in advancing their careers in regulatory submissions and compliance are encouraged to apply for this opportunity. Eligible candidates should send their updated resume to Lupin Biotech and explore career opportunities in biotechnology regulatory affairs. Regulatory Affairs Job at Lupin Biotech
