Sun Pharma Hiring Executive – Regulatory Affairs

Sun Pharma Hiring M.Pharm Professionals – Executive Regulatory Affairs | 3–6 Years | Baroda R&D

Sun Pharmaceutical Industries Ltd is inviting applications for the position of Executive – Regulatory Affairs under the R&D1 Regulatory Affairs business unit at its Tandalja R&D center, Baroda. This is a full-time opportunity for M.Pharm professionals with 3–6 years of experience in global regulatory submissions, dossier compilation, and lifecycle management. The role focuses on handling regulatory submissions for highly regulated markets including the US, EU, Australia, Canada, Israel, and Palestine.

If you have hands-on exposure to ANDA submissions, CTD/eCTD dossier preparation, query response management, and regulatory compliance for solid oral and non-oral dosage forms, this role offers strong career growth in one of India’s leading pharmaceutical companies.

---

Company Overview

Sun Pharmaceutical Industries Ltd is one of the largest specialty generic pharmaceutical companies in the world and India’s leading pharma organization by market capitalization. The company operates in over 100 countries and has a strong presence in regulated markets such as the United States, Europe, Canada, and Australia.

With advanced manufacturing facilities and robust R&D capabilities, Sun Pharma focuses on quality-driven drug development, regulatory compliance, and lifecycle management strategies that ensure timely product approvals and sustained global market access. The Regulatory Affairs division plays a critical role in securing approvals for complex generics, specialty formulations, and innovative dosage forms.

The Baroda R&D center is a key hub for dossier preparation, global submission management, and regulatory operations, supporting Sun Pharma’s commitment to delivering safe, effective, and affordable medicines worldwide.

---

Job Role & Responsibilities

As Executive – Regulatory Affairs, you will manage end-to-end regulatory submission activities for multiple international markets while ensuring compliance with US FDA, EMA, Health Canada, TGA, and other regional regulatory authorities.

Dossier Compilation & Submission Management

• Compile and review regulatory dossiers for US, EU, Australia, Canada, Israel, and other ROW markets.
• Handle CTD and eCTD submissions for solid oral and non-oral dosage forms.
• Ensure accuracy, completeness, and alignment with global regulatory guidelines.
• Manage timelines for dossier submission and query response within defined regulatory targets.

Query Response & Regulatory Review

• Review query responses prepared by regulatory associates before submission to health authorities.
• Evaluate documents received from cross-functional stakeholders for dossier compilation and lifecycle management.
• Ensure responses meet technical, scientific, and regulatory standards.

Lifecycle Management

• Oversee post-approval variations, amendments, and regulatory updates for US, EU, Canada, and Israel markets.
• Support regulatory strategy execution to maintain uninterrupted product approvals.
• Act as single point of contact for regulatory submission activities for Israel and Palestine markets.

Team & Project Coordination

• Allocate regulatory projects to associates and supervise submission progress.
• Coordinate with formulation development, analytical R&D, quality assurance, manufacturing, and regulatory operations teams.
• Ensure smooth execution of submission activities across multiple markets.

This role directly contributes to global drug approval processes, regulatory risk mitigation, and sustained compliance across international markets. It demands precision, regulatory expertise, and strong project management capabilities.

---

Eligibility / Qualifications

Educational Qualification

M.Pharm

Relevant Specializations: Pharmaceutics, Pharmaceutical Analysis, Regulatory Affairs, Industrial Pharmacy, Pharmaceutical Chemistry, Quality Assurance, Pharmacology.

Experience

• 3–6 years of experience in Regulatory Affairs within a pharmaceutical company.
• Hands-on experience in dossier compilation for US, EU, Canada, Australia, and other regulated markets.
• Experience in lifecycle management and post-approval submissions.
• Familiarity with ANDA filings, global regulatory submissions, and compliance documentation.

Key Skills Required

• Strong knowledge of CTD/eCTD format and regulatory documentation standards.
• Understanding of US FDA, EMA, Health Canada, TGA, and international regulatory guidelines.
• Excellent documentation and review skills.
• Ability to manage multiple projects under strict submission timelines.
• Strong coordination and leadership skills to manage regulatory associates.

---

Location & Employment Details

• Location: Tandalja R&D, Baroda (Vadodara), Gujarat
• Department: R&D1 Regulatory Affairs
• Job Grade: G12A
• Employment Type: Full-time
• Experience Level: 3–6 Years

Salary details are not publicly disclosed. Compensation is aligned with industry standards for regulatory affairs executives in the pharmaceutical R&D sector.

---

Application Process

Interested and eligible candidates can apply through the official Sun Pharma careers portal using the link below:

Apply Here: https://careers.sunpharma.com/job/Baroda-Executive-Regulatory-&-Business-Continuity/42583144/

Applicants are advised to submit updated CVs highlighting regulatory submission experience, market exposure, and lifecycle management expertise.

---

Frequently Asked Questions (FAQs)

1. What markets will this role handle?

This position manages regulatory submissions for US, EU, Australia, Canada, Israel, and related ROW markets.

2. Is prior ANDA experience required?

Yes, experience in ANDA or global dossier submissions is highly preferred.

3. What dosage forms are covered?

Both solid oral and non-oral dosage forms are included under this role.

4. Is this role suitable for freshers?

No. Candidates must have 3–6 years of relevant regulatory affairs experience.

5. Does this role involve team management?

Yes, the executive will allocate projects to regulatory associates and oversee submission activities.

---

Summary

Company	Sun Pharmaceutical Industries Ltd
Vacancies	Executive – Regulatory Affairs
Required Education	M.Pharm (Pharmaceutics, Pharmaceutical Analysis, Regulatory Affairs, Industrial Pharmacy, Pharmaceutical Chemistry, Quality Assurance, Pharmacology)
Experience	3–6 Years in Global Regulatory Submissions & Lifecycle Management