Sun Pharma has announced a hiring opportunity for experienced professionals in the Regulatory Affairs (US Group). This role is ideal for candidates with an M.Pharm qualification who have experience in regulatory submissions and compliance with global regulatory guidelines. The position is based in Baroda and offers an excellent opportunity to work with one of India’s leading pharmaceutical companies.

Candidates with a strong understanding of regulatory frameworks such as USFDA and ICH guidelines will have the opportunity to contribute to global regulatory submissions and product registrations.

Regulatory Affairs Job Overview

Company: Sun Pharma
Department: Regulatory Affairs (US Group)
Qualification: M.Pharm
Experience: 2–5 Years
Job Location: Baroda, Gujarat, India
Employment Type: Full-Time

Roles and Responsibilities

Professionals selected for this role will be responsible for managing regulatory submissions and ensuring compliance with international regulatory standards.

Key responsibilities include:

• Strong understanding of USFDA, ICH guidelines, and regional regulatory requirements including the US, EU, and India.
• Preparation, compilation, and submission of regulatory dossiers such as CTD and eCTD.
• Handling submissions for NDAs, ANDAs, MAAs, and post-approval changes.
• Supporting the development of regulatory strategies for new pharmaceutical products and markets.
• Coordinating with cross-functional teams including CDMO, R&D, and manufacturing departments to collect required documentation.
• Responding to regulatory authority queries and deficiency letters.
• Maintaining regulatory databases and tracking submission timelines and approvals.

Required Qualifications

To be eligible for this role, candidates should meet the following requirements:

• M.Pharm degree in a relevant pharmaceutical discipline
• 2–5 years of experience in Regulatory Affairs
• Experience working with regulatory submissions and dossier preparation
• Strong knowledge of USFDA and ICH regulatory guidelines
• Good coordination and communication skills

Salary and Benefits

Selected candidates can expect a competitive salary and benefits package depending on experience and company policy.

Estimated Salary Range: ₹6,00,000 – ₹10,00,000 per year

Additional benefits may include:

• Career growth opportunities in global regulatory affairs
• Exposure to international regulatory submissions
• Professional development within a leading pharmaceutical organization
• Health and employee benefits as per company policy

How to Apply

Interested and eligible candidates can apply by sending their updated resume to the email address below.

Email: Rosemary.varghese@sunpharma.com

Applicants are advised to mention the position “Regulatory Affairs – US Group” in the subject line while sending their application.

Early application is recommended as positions may close once suitable candidates are selected.