Sun Pharmaceutical Industries Ltd has announced an opportunity for the position of Executive – Regulatory Affairs – EM Market at its Gurgaon – R&D location. The role focuses on regulatory submissions, product approvals, variations, regulatory query responses, and lifecycle management of pharmaceutical products.
The selected professional will support regulatory activities for the WHO and Sub-Saharan Africa markets, with a focus on preparing and reviewing quality dossiers and ensuring submissions meet applicable country requirements.
This position is particularly relevant for professionals working in Pharmaceutical Regulatory Affairs, CMC documentation, dossier preparation, product lifecycle management, and regulatory compliance.
Sun Pharma Recruitment 2026 – Job Highlights
| Particulars | Details |
|---|---|
| Company | Sun Pharmaceutical Industries Ltd |
| Job Title | Executive – Regulatory Affairs – EM Market |
| Department | Regulatory Affairs |
| Function | R&D |
| Job Location | Gurgaon, India |
| Markets Covered | WHO & Sub-Saharan Africa |
| Key Area | CMC Dossiers / Regulatory Submissions |
| Experience | Not specified |
| Qualification | Not specified |
| Employment Type | Not specified |
| Salary / CTC | Not specified |
| Application Mode | Not specified in the provided vacancy |
About Sun Pharmaceutical Industries Ltd
Sun Pharmaceutical Industries Ltd is a pharmaceutical company involved in the development and manufacturing of medicines across various therapeutic areas and markets.
The advertised Regulatory Affairs position is based within the Gurgaon R&D function and is focused on regulatory activities associated with pharmaceutical products intended for international markets.
Job Description
The Executive – Regulatory Affairs – EM Market will be responsible for supporting regulatory submissions and lifecycle management activities for pharmaceutical products in WHO and Sub-Saharan Africa markets.
The role includes preparing and reviewing CMC documentation, assessing development and manufacturing-related documents, responding to regulatory deficiencies, preparing variation submissions, handling re-registration dossiers, and maintaining regulatory compliance records.
The position requires coordination with relevant stakeholders to support timely regulatory approvals and ensure that product information and regulatory documentation remain appropriately updated.
Regulatory Affairs – New Product Submissions
One of the major responsibilities of the role is supporting regulatory submissions for new pharmaceutical products.
The selected candidate may be responsible for:
- Reviewing and preparing CMC dossiers for new product submissions.
- Assessing the completeness and adequacy of regulatory documentation.
- Reviewing development-related reports before submission activities begin.
- Reviewing scale-up reports.
- Evaluating product specifications.
- Reviewing stability protocols.
- Checking relevant product artworks.
- Assessing documentation before initiation of exhibit batches.
- Coordinating with relevant stakeholders to resolve documentation gaps.
CMC Dossier Preparation
CMC documentation forms an important part of the position.
The candidate will work with information relating to areas such as:
- Chemistry
- Manufacturing
- Controls
- Product specifications
- Stability
- Scale-up activities
- Manufacturing sites
- Testing parameters
- Supporting technical documentation
The objective is to help ensure that regulatory dossiers are appropriately prepared for submission in the applicable markets.
Regulatory Approval and Deficiency Responses
The role also involves supporting products after regulatory submission.
Responsibilities include:
- Reviewing regulatory authority deficiencies or queries.
- Preparing responses to regulatory questions.
- Coordinating relevant information required for responses.
- Reviewing response documents for completeness.
- Supporting activities intended to facilitate regulatory approval.
- Maintaining appropriate records of regulatory correspondence and responses.
Product Lifecycle Management
A significant part of the role involves lifecycle management of pharmaceutical formulations.
The selected candidate will prepare and review regulatory variations required for changes to approved products.
These activities may include changes related to:
- API vendors
- Testing parameters
- ROS-related changes
- Drug product manufacturing sites
- Product harmonization
- Other approved product changes requiring regulatory assessment
The candidate will need to assess applicable country requirements and prepare appropriate regulatory documentation.
Variation Management
Regulatory variations may be required when changes are introduced to an approved pharmaceutical product.
The role includes:
- Preparing variation submissions.
- Reviewing variation documentation.
- Assessing changes against country-specific requirements.
- Supporting regulatory approval of post-approval changes.
- Coordinating with relevant technical and cross-functional stakeholders.
- Reviewing the regulatory impact of proposed changes.
Re-Registration and PCH Dossiers
The position also includes preparation and review of re-registration and PCH dossiers.
Responsibilities may include:
- Preparing re-registration documentation.
- Reviewing PCH dossiers.
- Ensuring required information is appropriately compiled.
- Coordinating dossier submission to regional offices or regulatory authorities.
- Supporting responses or additional documentation where required.
Regulatory Compliance
The selected candidate will also support ongoing regulatory compliance activities.
Key responsibilities include:
- Preparing approval packages after receipt of regulatory approvals.
- Reviewing approval documentation before circulation.
- Sharing approval packages with relevant stakeholders.
- Updating approval information following regulatory queries and variations.
- Maintaining comprehensive product information in the central repository.
- Reviewing the regulatory impact of variations.
- Assessing the impact of change controls on regulatory filings.
- Ensuring relevant regulatory information remains current and accessible.
Key Responsibilities
The overall responsibilities of the Executive – Regulatory Affairs role include:
- Preparing and reviewing regulatory CMC dossiers.
- Supporting new product submissions.
- Reviewing technical documents before exhibit batch initiation.
- Responding to regulatory deficiencies and queries.
- Managing lifecycle activities for pharmaceutical formulations.
- Preparing and reviewing variations.
- Supporting re-registration and PCH submissions.
- Coordinating regulatory documentation with regional offices and authorities.
- Preparing and circulating regulatory approval packages.
- Maintaining product information in the central repository.
- Reviewing regulatory impacts of variations and change controls.
- Supporting timely regulatory approvals and compliance.
Required Knowledge and Skills
Although specific qualification and experience requirements are not provided in the supplied vacancy, the responsibilities indicate that the role requires knowledge of areas such as:
Regulatory Affairs
- Pharmaceutical regulatory submissions
- Regulatory dossier preparation
- Regulatory authority queries
- Deficiency response preparation
- Product approvals
- Regulatory compliance
CMC
- Chemistry, Manufacturing and Controls documentation
- Product specifications
- Stability documentation
- Scale-up reports
- Manufacturing information
- Technical product documentation
Lifecycle Management
- Post-approval changes
- Variations
- API vendor changes
- Manufacturing site changes
- Testing parameter changes
- Product harmonization
- Re-registration activities
Professional Skills
- Strong documentation skills
- Attention to detail
- Regulatory document review
- Cross-functional coordination
- Ability to manage multiple regulatory activities
- Understanding of country-specific regulatory requirements
- Effective communication and stakeholder coordination
Work Location
Gurgaon – R&D
The position is associated with Sun Pharmaceutical Industries Ltd’s R&D function in Gurgaon.
The provided vacancy information does not specify whether the position is office-based, hybrid, or remote.
Salary / CTC
The salary or CTC for the Executive – Regulatory Affairs – EM Market position has not been specified in the provided vacancy details.
Candidates should confirm the compensation and other employment terms through the official Sun Pharma recruitment process.
Experience Requirements
The supplied job information does not specify a minimum or maximum number of years of experience.
Candidates should therefore review the official recruitment listing for the latest eligibility requirements before applying.
Educational Qualification
A specific educational qualification has not been mentioned in the supplied vacancy information.
Considering the technical nature of the position, candidates should refer to the official Sun Pharma job listing for the exact qualification requirements applicable to this role.
Selection Process
The detailed selection process has not been provided.
Candidates may be assessed based on their relevant regulatory affairs knowledge, pharmaceutical documentation experience, CMC understanding, lifecycle management exposure, communication abilities, and suitability for the role.
The exact recruitment stages should be confirmed with Sun Pharmaceutical Industries Ltd.
How to Apply
The supplied vacancy information does not include an official application URL or recruitment email address.
Candidates interested in this opportunity should locate the position through the official Sun Pharmaceutical Industries Ltd careers/recruitment channel and follow the company’s application procedure.
Important Details Before Applying
- Company: Sun Pharmaceutical Industries Ltd
- Position: Executive – Regulatory Affairs – EM Market
- Location: Gurgaon – R&D
- Primary markets: WHO and Sub-Saharan Africa
- Major function: Regulatory Affairs
- Key work: CMC submissions, approvals, deficiency responses, variations, lifecycle management and compliance
- Experience requirement: Not specified in the supplied information
- Educational qualification: Not specified in the supplied information
- Salary/CTC: Not specified
- Application link: Not provided in the supplied vacancy
- Candidates should verify the latest official job listing before applying.
Frequently Asked Questions
1. What is the job title at Sun Pharma?
The position is Executive – Regulatory Affairs – EM Market.
2. Where is this Sun Pharma job located?
The position is based at Gurgaon – R&D.
3. Which markets will this role support?
The role focuses on WHO and Sub-Saharan Africa markets.
4. What is the primary function of this position?
The role is focused on Pharmaceutical Regulatory Affairs, including submissions, approvals, variations, lifecycle management, and regulatory compliance.
5. Does the role involve CMC dossiers?
Yes. Reviewing and preparing CMC dossiers for new product submissions is one of the listed responsibilities.
6. Does this position involve regulatory query responses?
Yes. The role includes reviewing and preparing responses to regulatory deficiencies and queries.
7. What lifecycle management activities are mentioned?
The vacancy mentions variations involving API vendor changes, ROS/test parameter changes, drug product site changes, product harmonization, re-registration, and PCH dossiers.
8. Does the role involve regulatory compliance?
Yes. Responsibilities include approval-package management, central product-information maintenance, and assessment of regulatory impacts from variations and change controls.
9. Is salary information available?
No. Salary/CTC has not been specified in the provided vacancy details.
10. Is the required experience mentioned?
No specific experience range is provided in the supplied information.
Important Note
Job requirements, eligibility criteria, salary, recruitment timelines, work arrangements, and application procedures may change. Candidates should verify the latest information through the official Sun Pharmaceutical Industries Ltd recruitment channel before applying. This article is based on the vacancy information supplied and does not guarantee selection or employment.