Regulatory Affairs Executive | Sun Pharma Hiring

Regulatory Affairs Executive: Sun Pharma is inviting applications for the position of Executive – Regulatory Affairs – EM Market at its Gurugram location. This opportunity is suitable for pharmaceutical professionals interested in building or advancing their careers in Regulatory Affairs, CMC documentation, regulatory submissions, product lifecycle management, and regulatory compliance for international markets.

The role offers exposure to regulatory activities associated with WHO Sub-Saharan Africa markets, including new product submissions, responses to regulatory queries, variations, re-registration, and lifecycle management of pharmaceutical formulations.

Regulatory Affairs Executive Job Highlights

About the Role

The selected candidate will be responsible for supporting a broad range of regulatory affairs activities for emerging markets, with particular emphasis on WHO Sub-Saharan Africa markets.

The position involves preparing and reviewing regulatory documentation, coordinating responses to regulatory deficiencies and queries, managing product variations, and supporting the regulatory lifecycle of pharmaceutical products.

A key aspect of the role will be ensuring that regulatory dossiers and supporting documentation are complete, accurate, compliant with country-specific requirements, and submitted within the required timelines.

Key Responsibilities

1. New Product Regulatory Submissions

The candidate will support the preparation and review of regulatory dossiers for new product submissions.

2. Regulatory Approval & Query Management

The role will also involve supporting the regulatory approval process by managing deficiencies and regulatory queries.

3. Product Lifecycle Management

Regulatory Affairs professionals play an important role throughout the lifecycle of a pharmaceutical product. In this position, the candidate will support various lifecycle management activities.

4. Regulatory Compliance

The position will also involve maintaining regulatory compliance throughout the product lifecycle.

Educational Qualification

Candidates with the following qualifications are eligible to apply:

• B.Pharm – Bachelor of Pharmacy
• M.Pharm – Master of Pharmacy
• Pharm.D – Doctor of Pharmacy

Professionals with an academic background in pharmacy and an interest in Regulatory Affairs and international pharmaceutical regulations may find this opportunity relevant.

Key Skills Required

Candidates should ideally possess or develop knowledge of:

• Regulatory Affairs
• Regulatory Compliance
• CMC Documentation
• Regulatory Dossier Preparation
• Pharmaceutical Manufacturing
• Chemistry
• Product Lifecycle Management
• Regulatory Submissions
• Post-Approval Variations
• Change Control
• Stability Documentation
• Regulatory Query Management
• API and Drug Product Changes
• Re-registration Dossiers
• International/Emerging Market Regulations

Strong documentation, analytical, communication, coordination, and review skills can also be valuable for successfully handling regulatory activities.

Who Can Apply?

The position is open to candidates with 0–6 years of experience, making it potentially relevant to both early-career pharmaceutical professionals and candidates with prior Regulatory Affairs experience.

Freshers with a relevant pharmacy qualification may consider the role if the employer’s current eligibility criteria permit applications from candidates without prior industry experience.

Professionals already working in areas such as Regulatory Affairs, CMC, Quality Assurance, Regulatory Compliance, Pharmaceutical Development, or related functions may also find the responsibilities aligned with their experience.

International Regulatory Exposure

One of the notable aspects of this position is its focus on EM (Emerging Market) regulatory activities, including WHO Sub-Saharan Africa markets.

Working in this area can provide exposure to:

• International regulatory documentation
• Country-specific submission requirements
• Regulatory variations
• Product registrations and re-registrations
• Regulatory agency queries
• CMC requirements
• Post-approval lifecycle management
• Cross-functional pharmaceutical operations

Such exposure can be relevant for professionals aiming to develop expertise in global regulatory affairs and international pharmaceutical markets.

Job Location

Gurugram, Haryana

Employment Details

Employment Type: Full-Time, Permanent

Experience: 0–6 Years

Salary: Not Disclosed

Why This Role May Be Relevant for Regulatory Affairs Professionals

This position covers several important areas of the regulatory lifecycle, from initial CMC dossier preparation and new product submissions to regulatory query responses, variations, re-registration, and post-approval compliance.

For pharmacy professionals looking to develop experience in international regulatory operations, the role provides exposure to multiple stages of pharmaceutical product registration and lifecycle management.

How to Apply

Interested candidates should verify the current availability of the position and the latest eligibility requirements before submitting an application. Applicants are advised to refer to Sun Pharma’s official careers channel or the original job posting for the most up-to-date application information.

Quick Summary

Position: Executive – Regulatory Affairs – EM Market

Company: Sun Pharma

Experience: 0–6 Years

Location: Gurugram

Qualification: B.Pharm / M.Pharm / Pharm.D

Employment: Full-Time, Permanent

Department: Legal & Regulatory

Industry: Pharmaceutical & Life Sciences

Salary: Not Disclosed

Disclaimer: This job blog has been prepared based on the job information provided. Job responsibilities, eligibility criteria, vacancy status, and other details may change. Candidates should verify the latest information directly through the company’s official recruitment channels before applying.

Editorial Note

This article has been carefully researched and written by Deepak Rajput with a focus on accuracy, clarity, and evidence-based healthcare information. Pharmaacademias.com