Sun Pharmaceutical Industries Ltd has an opportunity for an experienced professional in India Regulatory Affairs at its Tandalja – R&D location in Baroda. The position is associated with the R&D1 Regulatory Affairs business unit and carries the internal job title Manager II – India Regulatory and Business Continuity.
The role focuses on regulatory strategy and submission activities for pharmaceutical products intended for the Indian market. The selected professional will work on CMC documentation, clinical trial and bioequivalence documents, regulatory dossiers, SUGAM portal submissions, product labelling, prescribing information, and regulatory assessments.
The position requires a Master’s degree in Pharmacy (M.Pharm) and 8–10 years of experience, making it relevant for experienced regulatory affairs professionals with substantial exposure to Indian pharmaceutical registrations.
Sun Pharma Recruitment 2026 – Job Highlights
| Particulars | Details |
|---|---|
| Company | Sun Pharmaceutical Industries Ltd |
| Advertised Position | Senior Executive – India Regulatory Affairs |
| Internal Job Title | Manager II – India Regulatory and Business Continuity |
| Business Unit | R&D1 Regulatory Affairs |
| Job Grade | G11A |
| Location | Tandalja / Baroda, Gujarat |
| Functional Area | India Regulatory Affairs |
| Qualification | M.Pharm |
| Experience | 8–10 Years |
| Travel | Not Applicable / NA |
| Key Area | Indian Regulatory Submissions |
| Salary / CTC | Not specified |
About Sun Pharmaceutical Industries Ltd
Sun Pharmaceutical Industries Ltd is a pharmaceutical organization with operations across research, development, manufacturing, and commercialization of medicines.
This opportunity is part of the company’s R&D Regulatory Affairs function and is focused specifically on regulatory requirements for products being registered and developed for the Indian market.
Job Description
The Senior Executive – India Regulatory Affairs will support and manage regulatory activities associated with the registration of pharmaceutical products in India.
The role requires coordination with cross-functional teams to collect and review technical and clinical documentation, develop regulatory strategies, compile dossiers, prepare applications, and submit relevant applications through the SUGAM portal.
The professional will also evaluate scientific literature, prepare safety and efficacy rationales, review product information and labelling, and ensure that regulatory submissions are aligned with applicable requirements.
Educational Qualification
Candidates should have:
- Master’s degree in Pharmacy (M.Pharm)
The vacancy specifically lists M.Pharm as the required educational qualification.
Experience Requirements
The position requires 8–10 years of professional experience.
Candidates should ideally have substantial experience in areas related to:
- India Regulatory Affairs
- Pharmaceutical regulatory submissions
- CMC documentation
- Clinical trial documentation
- Bioequivalence documentation
- Regulatory dossier compilation
- Indian product registration
- Regulatory strategy
Key Responsibilities
1. India Regulatory Strategy
The selected candidate will be responsible for evaluating regulatory strategies for pharmaceutical products intended for registration in India.
Responsibilities include:
- Assessing regulatory requirements applicable to proposed products.
- Developing or evaluating appropriate submission strategies.
- Supporting regulatory pathways for new products.
- Considering regulatory requirements throughout the product registration process.
2. Cross-Functional Coordination
The role requires close coordination with various internal teams.
The candidate will:
- Coordinate with cross-functional teams to obtain documents required for Indian regulatory submissions.
- Follow up on final technical and clinical documentation.
- Coordinate the compilation of required submission materials.
- Ensure relevant documents are available for dossier preparation.
3. CMC Documentation Review
CMC documentation is a major part of the position.
Responsibilities include:
- Reviewing CMC documents intended for inclusion in regulatory dossiers.
- Checking documentation against applicable regulatory guidelines.
- Reviewing specifications for bulk drugs.
- Reviewing formulation specifications.
- Assessing whether technical information meets regulatory expectations.
4. Clinical Trial and Bioequivalence Documentation
The position also involves reviewing clinical and bioequivalence-related documentation.
The selected professional will:
- Review clinical trial documents intended for regulatory applications.
- Review bioequivalence study documentation.
- Ensure relevant documents are suitable for inclusion in regulatory submissions.
- Coordinate with appropriate teams to obtain final clinical and BE documents.
5. Regulatory Literature Search
The role includes scientific literature research in support of regulatory applications.
Responsibilities may involve:
- Searching relevant scientific literature through appropriate online sources.
- Reviewing published information according to the regulatory application strategy.
- Identifying relevant evidence for regulatory documentation.
- Using published literature to support regulatory assessments.
6. Safety and Efficacy Rationale
The selected candidate will prepare scientific rationale related to the safety and efficacy of products.
This may include:
- Reviewing published scientific literature.
- Assessing relevant safety information.
- Assessing available efficacy information.
- Preparing documented rationale for new drugs or Fixed Dose Combinations (FDCs).
- Aligning the rationale with the requirements of the applicable regulatory application.
7. SEC Referral Documentation
The role includes preparing an executive summary for SEC referral in cases involving drugs that have not been approved in India.
The candidate will compile relevant information in an appropriate format to support the regulatory review process.
8. Regulatory Dossier Compilation
The position involves coordinating final documentation and compiling regulatory dossiers.
The candidate will:
- Obtain final CMC documents.
- Obtain final clinical trial documentation.
- Obtain final bioequivalence documents.
- Review final submission materials.
- Compile the required regulatory dossier.
- Prepare documentation for regulatory submission.
9. SUGAM Portal Submissions
One of the key responsibilities is filing regulatory applications through the SUGAM portal.
The role may involve submitting:
- ND applications
- SND applications
- FDC applications
- Clinical trial-related applications
These submissions support regulatory permissions associated with domestic manufacturing, marketing, and clinical trial activities, as applicable.
10. Product Labelling and Artwork Review
The selected professional will also review product information used for pharmaceutical packaging.
Responsibilities include:
- Reviewing draft labels.
- Reviewing specimen labels.
- Reviewing carton artwork.
- Checking product information against regulatory requirements.
- Identifying regulatory issues requiring correction.
11. Prescribing Information
The role also includes preparation of prescribing information.
The candidate will:
- Review relevant international prescribing information.
- Use appropriate international product information as a reference.
- Prepare prescribing information for applicable regulatory requirements.
Required Regulatory Knowledge
The position requires strong knowledge of pharmaceutical regulatory affairs, particularly the Indian regulatory environment.
Relevant areas include:
- Indian drug registration
- Regulatory strategy
- CMC submissions
- Clinical trial applications
- Bioequivalence documentation
- ND applications
- SND applications
- FDC applications
- SUGAM portal submissions
- Product labelling
- Prescribing information
- Regulatory dossier compilation
- Scientific literature assessment
Required Professional Skills
Candidates should be capable of handling complex regulatory documentation and coordinating with multiple functions.
Important skills include:
- Regulatory document review
- Dossier preparation
- Regulatory strategy development
- Scientific literature evaluation
- Technical writing
- Cross-functional coordination
- Attention to detail
- Regulatory compliance
- Analytical thinking
- Documentation management
- Stakeholder communication
- Project and timeline management
Work Location
Tandalja – R&D, Baroda, Gujarat
The vacancy identifies Baroda as the location and Tandalja – R&D in the position details.
The source does not specify a remote or hybrid work arrangement.
Travel Requirements
The vacancy lists the Travel Estimate as NA, meaning no specific travel requirement is provided for this position.
Salary / CTC
The salary or CTC has not been specified in the provided vacancy details.
Candidates should confirm compensation, benefits, and other employment terms directly through the official Sun Pharma recruitment process.
Benefits and Career Development
Sun Pharma’s vacancy information highlights a focus on employee development, collaboration, well-being, and professional growth.
The company states that it provides benefits and opportunities intended to support personal and professional development. Specific benefits applicable to this particular position should be confirmed with the employer.
Selection Process
The detailed selection process is not provided in the supplied vacancy information.
Given the seniority of the position, candidates should be prepared to discuss their experience in:
- India Regulatory Affairs
- Pharmaceutical registrations
- CMC documentation
- Clinical trial and BE submissions
- Regulatory strategy
- Dossier compilation
- SUGAM submissions
- Regulatory literature assessment
- Cross-functional coordination
The actual recruitment process and assessment stages should be confirmed by Sun Pharmaceutical Industries Ltd.
How to Apply
The provided vacancy details do not include a direct application URL or recruitment email address.
Interested candidates should refer to the official Sun Pharmaceutical Industries Ltd careers portal and search for the relevant India Regulatory Affairs position before submitting an application.
Important Details Before Applying
- Company: Sun Pharmaceutical Industries Ltd
- Position: Senior Executive – India Regulatory Affairs
- Internal Job Title: Manager II – India Regulatory and Business Continuity
- Business Unit: R&D1 Regulatory Affairs
- Job Grade: G11A
- Location: Tandalja – R&D, Baroda
- Qualification: M.Pharm
- Experience: 8–10 years
- Travel Estimate: NA
- Major focus: Indian pharmaceutical regulatory submissions
- Important areas: CMC, clinical trials, BE, SUGAM, dossier compilation, labelling and prescribing information
- Salary/CTC: Not disclosed
- Application link: Not included in the supplied vacancy
Frequently Asked Questions
1. What is the advertised position at Sun Pharma?
The advertised position is Senior Executive – India Regulatory Affairs.
2. What is the internal job title?
The vacancy lists the internal job title as Manager II – India Regulatory and Business Continuity.
3. Which business unit does the position belong to?
The position is part of R&D1 Regulatory Affairs.
4. What is the job grade?
The listed job grade is G11A.
5. Where is the position located?
The position is listed at Tandalja – R&D, Baroda, Gujarat.
6. What qualification is required?
The vacancy specifies a Master’s degree in Pharmacy (M.Pharm).
7. How much experience is required?
The specified experience range is 8–10 years.
8. Does the role involve SUGAM portal submissions?
Yes. The responsibilities include filing ND, SND, and FDC applications through the SUGAM portal, including applications related to domestic manufacturing/marketing permissions and clinical trial permissions, as applicable.
9. Does the role involve clinical trial and bioequivalence documents?
Yes. Reviewing clinical trial and bioequivalence study documents for regulatory applications is part of the responsibilities.
10. Is the salary mentioned?
No. The salary/CTC has not been specified in the provided vacancy information.
Important Note
Job responsibilities, eligibility criteria, salary, benefits, recruitment timelines, and other employment conditions may be changed or updated by the employer. Candidates should verify the latest information through the official Sun Pharmaceutical Industries Ltd recruitment channel before applying. The company’s general job-description disclaimer also indicates that assigned duties may change and that the listed responsibilities are not an exhaustive inventory of every possible duty associated with the position.