Sun Pharma Hiring Senior Executive – Regulatory Affairs (US Group)

Sun Pharma Hiring Senior Executive – Regulatory Affairs (US Group) | M.Pharm | Vadodara

Sun Pharma is inviting applications for the position of Senior Executive in the Regulatory Affairs – US Group at its Vadodara location. This opportunity is ideal for experienced M.Pharm professionals looking to build a long-term career in pharmaceutical regulatory affairs, dossier management, and USFDA compliance operations.

The pharmaceutical regulatory affairs sector continues to see strong hiring demand due to increasing global product filings, ANDA submissions, lifecycle management requirements, and evolving international compliance standards. Professionals with expertise in regulatory documentation, CTD submissions, pharmaceutical compliance, and US market regulations are highly valued across the pharma industry.

Candidates with 4 to 6 years of experience in US Regulatory Affairs and exposure to pharmaceutical dossier preparation, submission coordination, and regulatory documentation management are encouraged to apply.

Company Overview

Sun Pharma is one of India’s largest pharmaceutical companies with a strong global presence across regulated and emerging markets. The company operates in more than 100 countries and is known for manufacturing high-quality pharmaceutical formulations, specialty medicines, and active pharmaceutical ingredients.

Sun Pharma’s Regulatory Affairs division plays a critical role in supporting global product registrations, maintaining regulatory compliance, and managing pharmaceutical submissions for international markets including the United States.

Working with Sun Pharma provides exposure to:

• USFDA regulatory systems
• Global pharmaceutical compliance standards
• ANDA filing and lifecycle management
• Pharmaceutical documentation practices
• Cross-functional coordination with QA, QC, Production, and R&D teams
• International pharmaceutical market operations

The company offers strong career growth opportunities for professionals interested in regulatory strategy, pharmaceutical compliance, and global healthcare documentation systems.

Job Role & Responsibilities

The selected candidate will work in the Regulatory Affairs – US Group and support regulatory documentation, submission management, and compliance-related activities for the US pharmaceutical market.

Key Responsibilities

• Preparation, review, and compilation of regulatory dossiers and pharmaceutical documents
• Coordination for ANDA submissions and lifecycle management activities
• Managing CTD and eCTD documentation for regulated market submissions
• Reviewing regulatory data and ensuring compliance with USFDA guidelines
• Coordination with QA, QC, Production, Analytical Development, and R&D departments
• Supporting product registration activities for the US pharmaceutical market
• Reviewing pharmaceutical labeling and regulatory documentation
• Maintaining regulatory records and documentation databases
• Ensuring timely submission support and response tracking
• Supporting variation filings, amendments, and deficiency responses
• Maintaining compliance with current pharmaceutical regulatory requirements
• Participating in documentation review and quality compliance activities

Professionals with experience in pharmaceutical regulatory operations, submission management, regulatory compliance, and documentation control will find strong career growth in this role.

Eligibility / Qualifications

Candidates applying for this Regulatory Affairs pharma job should meet the following eligibility criteria.

Educational Qualification

• M.Pharm

Experience Required

• 4 to 6 years of relevant Regulatory Affairs experience
• Experience in US market regulatory affairs preferred

Preferred Skills

• Knowledge of USFDA regulatory requirements
• Experience in regulatory documentation and dossier compilation
• Understanding of CTD/eCTD submissions
• Strong pharmaceutical documentation practices
• Good communication and coordination skills
• Knowledge of pharmaceutical compliance systems
• Familiarity with lifecycle management activities
• Ability to work with cross-functional pharma teams
• Understanding of regulated market pharmaceutical operations

Relevant Educational Backgrounds

M.Pharm, Pharmaceutical Regulatory Affairs, Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Drug Regulatory Affairs, Pharmaceutical Analysis, Pharmaceutical Quality Assurance

Location & Salary

Job Location

• Vadodara, Gujarat

Expected Salary Range

Based on current pharmaceutical industry standards in Gujarat for Regulatory Affairs professionals with 4–6 years of experience, the estimated salary range may vary between ₹6 LPA to ₹10 LPA depending on regulatory exposure, US market experience, technical expertise, and previous organization.

Additional benefits may include:

• Performance incentives
• Corporate healthcare benefits
• Professional development opportunities
• Exposure to global pharmaceutical operations
• Long-term career growth in regulated markets

Application Process

Interested and eligible candidates can apply by sharing their updated resume directly with the recruitment team.

Email Your Resume To

• Rosemary.varghese@sunpharma.com

Candidates should mention:

• Current designation
• Total Regulatory Affairs experience
• US market exposure
• Current CTC
• Notice period

Early applications are recommended as pharmaceutical regulatory positions in reputed companies like Sun Pharma generally receive a high number of applications.

Frequently Asked Questions (FAQs)

1. What qualification is required for this Sun Pharma Regulatory Affairs job?

Candidates must have an M.Pharm qualification with relevant Regulatory Affairs experience.

2. How much experience is required for this role?

Applicants should have 4 to 6 years of Regulatory Affairs experience, preferably in the US market.

3. Is USFDA knowledge mandatory for this role?

Candidates with exposure to USFDA regulatory requirements and US market documentation will be preferred.

4. What is the job location for this vacancy?

The job location is Vadodara, Gujarat.

5. What is the estimated salary for this Regulatory Affairs role?

The estimated salary range is approximately ₹6 LPA to ₹10 LPA depending on experience and regulatory expertise.

6. How can candidates apply for this Sun Pharma job opening?

Interested candidates can send their updated CV to Rosemary.varghese@sunpharma.com.

Summary Table

Company	Sun Pharma
Department Vacancies	Regulatory Affairs – US Group, Senior Executive
Qualification	M.Pharm
Experience	4–6 Years
Location	Vadodara, Gujarat

Tagged as: Pharma Jobs in Vadodara