Lupin Hiring Senior Executive – Regulatory Affairs in Pune
Lupin is seeking applications for the position of Senior Executive – Regulatory Affairs at its Pune Biotech location in Maharashtra. The role will be in the area of CMC regulatory documentation, dossiers, regulatory submissions and working with cross functional teams to ensure that we meet the country specific regulatory requirements. (Senior Executive – Regulatory Affairs, 2026)
We are looking for applicants with postgraduate qualifications in Pharmacy or Biotechnology. The role would involve the preparation and review of regulatory dossiers, responding to queries, tracking product documentation and maintaining compliance throughout the product life cycle.
Job Details
| Particulars | Details |
| Company | Lupin |
| Job Title | Senior Executive – Regulatory Affairs |
| Department | Regulatory Affairs |
| Functional Area | CMC Regulatory Affairs |
| Location | Pune Biotech, Maharashtra |
| Qualification | Postgraduate qualification in Pharmacy or Biotechnology |
| Experience | Not specified in the supplied job description |
| Job Type | Not specified in the supplied listing |
| Application Mode | Online |
| Official Application |
About Lupin
Lupin is a pharma company with operations in many markets. The Regulatory Affairs people are responsible for the preparation and maintenance of the product documentation required for regulatory review and approval. (Senior Executive – Regulatory Affairs Job Details | Lupin, 2026) This particular role is focused on CMC documentation and working with the various internal departments to support regulatory submissions. (Senior Executive – Regulatory Affairs, 2026)
Job Responsibilities
The Senior Executive – Regulatory Affairs role has the following responsibilities as per the company’s job description.
1. CMC Document Review
Review the CMC documents received from the various cross-functional departments and provide input to ensure they are in line with the relevant regulatory requirements.
2. Regulatory Dossier Preparation
Prepare CMC sections and put together and review regulatory dossiers in accordance with the country specific submission requirements.
3. Regulatory Submission Tracking
Co-ordinate with the relevant departments to gather the documents and information required for the dossier. Monitor the process of collection and assist in ensuring that submissions get to the regulators in accordance with the approved timescales.
4. Regulatory Query Responses
Prepare and compile responses to regulatory questions in conjunction with cross functional teams, making sure they are submitted on time.
5. Interdepartmental Coordination
Coordinate with QA, QC, R&D and Manufacturing Science and Technology (MSAT) to obtain the source data required for regulatory submissions.
6. Regulatory Trackers and Documentation
Prepare and maintain product specific trackers to track documentation, submission progress and all other regulatory activities. (Senior Executive – Regulatory Affairs, 2026)
7. Product Lifecycle Management
Track changes, variations and process changes throughout the product lifecycle and update the regulatory documentation as appropriate to maintain compliance with the relevant requirements. (Senior Executive – Regulatory Affairs Job Details | Lupin, 2026)
The company may assign further responsibilities as may be required.
Eligibility Criteria
Candidates who are interested in the Lupin Senior Executive – Regulatory Affairs recruitment should have a look at the educational qualifications mentioned in the advertisement.
Educational Qualification
- Postgraduate qualification in Pharmacy.
- Masters in Biotechnology or a relevant Biotechnology qualification as stated in the advert.
The job description that’s been supplied doesn’t specify a minimum number of years’ experience. Candidates should check the actual advert or get in touch with the recruitment team if they need any further clarification on the experience requirement.
Key Skills Relevant to the Role
The responsibilities described in the advertisement indicate the importance of the following capabilities:
- CMC regulatory documentation and review
- Regulatory dossier preparation and compilation
- Country-specific regulatory submission requirements
- Regulatory inquiry reply preparation
- Cross-functional collaboration with QA, QC, R&D, and MSAT
- Documentation tracking and deadline management
- Change control and product lifecycle documentation
- Attention to detail and compliance regulations (Senior Executive – Regulatory Affairs Job Details | Lupin, 2026)
These are role related capabilities as reflected in the duties listed, not a separate published mandatory skills checklist.
Job Location
The company is based in Pune Biotech, Maharashtra, India.
Candidates should check Lupin’s official jobs page for the details on location, reporting line and all other employment terms.
How to Apply for Lupin Regulatory Affairs Jobs
Interested candidates can apply via Lupin’s official careers site.
- Visit the official Lupin job advert.
- Review the job description and ensure your postgraduate qualification meets the stated requirements.
- Select the application option and go through the online application process.
- Update your CV to reflect relevant experience in CMC documentation, dossier assembly, regulatory submissions, query handling and product lifecycle documentation where applicable.
- Just submit the application via the official portal.
Applicants must provide accurate details of their education and professional experience.
Frequently Asked Questions
1. Is Lupin hiring for Regulatory Affairs in Pune?
Yes, Lupin has a Senior Executive – Regulatory Affairs open at its Pune Biotech site.
2. What are the requirements?
The listing requires a postgraduate qualification in Pharmacy or Biotechnology.
3. What are the main responsibilities?
The role is to review CMC documentation, prepare regulatory dossiers, coordinate regulatory submissions, compiling query responses, tracking documentation, and updating product lifecycle as appropriate.
4. What level of experience is required?
The job description provided makes no mention of a minimum experience requirement. Candidates are advised to check the official advert for any further eligibility criteria.
5. Where is the job based?
The position is based at Pune Biotech in Maharashtra, India.
6. How can candidates apply?
Candidates can apply via the official Lupin careers site.
Lupin Recruitment Summary
| Category | Details |
| Company | Lupin |
| Position | Senior Executive – Regulatory Affairs |
| Department | Regulatory Affairs |
| Functional Focus | CMC documentation and regulatory submissions |
| Qualification | Postgraduate in Pharmacy or Biotechnology |
| Experience | Not specified in supplied description |
| Location | Pune Biotech, Maharashtra |
| Key Responsibilities | Dossier preparation, CMC review, query responses, submission tracking |
| Application Mode | Online |
| Apply Link |
Candidates with a postgraduate degree in Pharmacy or Biotechnology and relevant regulatory documentation experience can have a look at the official job posting for the Senior Executive – Regulatory Affairs role at Lupin in Pune.