Sun Pharmaceutical Industries Ltd is hiring for the position of Manager-2 – Regulatory & Business Continuity at its Gurgaon R&D location. The role is focused on regulatory activities for the US and OAM markets, including new product submissions, CMC dossier preparation, regulatory responses and lifecycle management.
The opportunity is suitable for experienced pharmaceutical regulatory affairs professionals with an M.Pharm qualification and 8–12 years of experience. Candidates should have strong exposure to the USFDA regulatory environment, CMC documentation, eCTD activities and post-approval lifecycle management.
Sun Pharma Recruitment 2026 – Job Highlights
| Particular | Details |
|---|---|
| Company | Sun Pharmaceutical Industries Ltd |
| Job Title | Manager-2 – Regulatory & Business Continuity |
| Business Unit | Regulatory & Business Continuity |
| Job Grade | G11A |
| Location | Gurgaon |
| Work Area | R&D |
| Market | US and OAM |
| Qualification | M.Pharm |
| Experience | 8–12 Years |
| Key Expertise | USFDA, CMC, Regulatory Submissions, Lifecycle Management |
| Salary / CTC | Not specified |
| Job Type | Full-time |
About Sun Pharmaceutical Industries
Sun Pharmaceutical Industries Ltd is a global pharmaceutical company engaged in the development and manufacturing of pharmaceutical products across multiple markets.
The current position is part of the company’s R&D-related regulatory function and focuses on regulatory submission, CMC documentation, product approvals and lifecycle management for the US and OAM markets.
About the Manager-2 – Regulatory & Business Continuity Role
The Manager-2 will be responsible for regulatory activities associated with new pharmaceutical product submissions and ongoing lifecycle management.
The role requires reviewing and preparing CMC dossiers, responding to regulatory deficiencies, handling variations and annual notifications, supporting labeling approvals and assessing the regulatory impact of changes to products and processes.
The position also involves coordination with cross-functional teams to ensure regulatory filings are prepared accurately and submitted within applicable timelines.
Educational Qualification / Eligibility Criteria
Candidates should have:
- M.Pharm qualification.
- Relevant pharmaceutical regulatory affairs experience.
- Strong understanding of US regulatory requirements.
- Experience with CMC documentation and regulatory submissions.
Experience Requirements
The specified experience requirement is:
8–12 years of professional experience
Candidates should have substantial experience in regulatory affairs, particularly involving the USFDA market and pharmaceutical CMC submissions.
Required Skills and Competencies
Candidates should possess the following knowledge and capabilities:
- Experience working with the USFDA market.
- Understanding of CMC Modules 1, 2 and 3.
- Expertise in CMC dossier preparation.
- Knowledge of regulatory submission processes.
- Experience in product lifecycle management.
- Understanding of variations and post-approval regulatory activities.
- Knowledge of eCTD compilation.
- Ability to review regulatory impact of change controls and variations.
- Strong cross-functional collaboration skills.
- Ability to coordinate regulatory activities across development and other relevant functions.
Key Responsibilities
New Product Regulatory Submissions
The selected candidate will support regulatory submissions for new products by:
- Reviewing and preparing CMC dossiers for new submissions.
- Assessing technical documents before initiation of exhibit batches.
- Reviewing development reports.
- Evaluating scale-up reports.
- Reviewing product specifications.
- Reviewing stability protocols.
- Assessing analytical validation documentation.
- Ensuring required documentation is adequate for regulatory submission activities.
Regulatory Approval and Deficiency Responses
The role includes supporting product approvals by:
- Reviewing regulatory authority deficiency letters or queries.
- Preparing appropriate responses to regulatory questions.
- Coordinating with relevant technical functions to obtain supporting information.
- Ensuring responses are appropriately documented to support regulatory approval.
Product Lifecycle Management
The Manager-2 will be involved in post-approval regulatory activities for pharmaceutical formulations, including:
- Preparing and reviewing variations.
- Managing annual notifications.
- Supporting labeling approval activities for US and OAM markets.
- Reviewing change controls from a regulatory perspective.
- Determining appropriate filing requirements based on country-specific regulations.
- Supporting regulatory submissions related to product changes.
Regulatory Compliance and Documentation
Responsibilities also include:
- Supporting eCTD compilation activities.
- Ensuring comprehensive product information is appropriately maintained in the central repository.
- Reviewing the regulatory impact of variations.
- Assessing the regulatory implications of change controls.
- Supporting appropriate regulatory filing decisions.
Cross-Functional Collaboration
The role requires coordination with relevant internal functions to collect technical information, evaluate regulatory requirements and prepare complete submission packages.
Effective collaboration will be required to support submission quality, regulatory compliance and timely project execution.
Work Location
The position is based in:
Gurgaon – R&D
India
The provided job description does not specify a remote or hybrid work arrangement.
Salary / CTC
The salary or CTC for the Manager-2 – Regulatory & Business Continuity position has not been disclosed in the provided vacancy information.
Candidates should confirm compensation details during the recruitment process.
Employee Benefits and Career Development
Sun Pharma states that it provides benefits and opportunities designed to support employee wellbeing and professional development.
The company describes its work environment around continuous learning, collaboration and professional growth. Specific benefits applicable to this particular position have not been detailed in the vacancy information.
Selection Process
The detailed selection process has not been specified in the available job description.
Candidates should follow Sun Pharma’s recruitment process and be prepared for the applicable interview or assessment stages communicated by the company.
How to Apply for Sun Pharma Recruitment 2026
Eligible candidates interested in the Manager-2 – Regulatory & Business Continuity position should apply through the official Sun Pharma recruitment process.
Before applying, candidates should ensure their resume clearly highlights:
- M.Pharm qualification
- 8–12 years of regulatory affairs experience
- USFDA regulatory experience
- CMC dossier preparation
- CMC Modules 1, 2 and 3 knowledge
- Regulatory submissions
- Lifecycle management
- Variations and change controls
- eCTD experience
- Cross-functional regulatory coordination
Important Details Before Applying
- Company: Sun Pharmaceutical Industries Ltd
- Position: Manager-2
- Business Unit: Regulatory & Business Continuity
- Job Grade: G11A
- Location: Gurgaon
- Function: R&D
- Qualification: M.Pharm
- Experience: 8–12 years
- Market: US and OAM
- Key expertise: USFDA, CMC, regulatory submissions and lifecycle management.
- The role includes new product submissions and post-approval regulatory activities.
- Knowledge of CMC Modules 1, 2 and 3 is required.
- Salary/CTC has not been specified.
Frequently Asked Questions
1. What is the job title at Sun Pharma?
The position is Manager-2 – Regulatory & Business Continuity.
2. Where is the Sun Pharma Manager-2 job located?
The position is based in Gurgaon within the R&D function.
3. What qualification is required?
Candidates should have an M.Pharm qualification.
4. How much experience is required?
The specified experience range is 8–12 years.
5. Which markets does this role cover?
The position focuses on regulatory activities for the US and OAM markets.
6. What regulatory experience is required?
Candidates should have experience with the USFDA market, CMC dossier preparation, regulatory submissions and lifecycle management.
7. What are CMC Modules 1, 2 and 3?
The job description specifically requires knowledge of CMC Modules 1, 2 and 3 as part of the regulatory submission responsibilities.
8. What are the major responsibilities?
Major activities include preparing CMC dossiers, reviewing development and technical documents, responding to regulatory deficiencies, managing variations and annual notifications, supporting labeling approvals and reviewing the regulatory impact of change controls.
9. Does the position involve lifecycle management?
Yes. The role includes lifecycle management activities for pharmaceutical formulations, including variations, annual notifications, labeling approvals and change-control-related regulatory filings.
10. Is eCTD experience relevant?
Yes. eCTD compilation is specifically listed under the regulatory compliance responsibilities.
11. What is the salary for this Sun Pharma position?
The salary or CTC has not been specified in the available job description.
Important Note
The responsibilities and qualifications in this article are based on the provided Sun Pharma vacancy information. Job availability, eligibility criteria, compensation, recruitment stages and assigned responsibilities may change according to business requirements. Candidates should verify the latest information through Sun Pharma’s official recruitment channel before applying.