Sun Pharmaceutical Industries Regulatory Affairs Executive

Regulatory Affairs Executive (M.Pharm) – 1–3 Yrs – Vadodara

Hiring M.Pharm Regulatory Affairs Executive with 1–3 years of experience in Vadodara. Apply now for global regulatory submissions at Sun Pharma!

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We are inviting passionate and detail-oriented Regulatory Affairs Executives to join Sun Pharma, a global leader in pharmaceuticals, at our Vadodara facility. This is an excellent opportunity for professionals eager to advance their careers in global regulatory affairs and make a real-world impact on patient access to quality medicines.

As part of our regulatory team, you will play a pivotal role in managing product registrations, renewals, and variations for ROW (Rest of the World) markets, including South Africa, Nepal, and MENA regions.

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Company Overview

Sun Pharmaceutical Industries Ltd., headquartered in Mumbai, is one of the world’s largest specialty generic pharmaceutical companies. With operations in over 100 countries, Sun Pharma is renowned for its commitment to innovation, affordability, and healthcare excellence.

Our robust global presence and adherence to international regulatory standards make Sun Pharma a trusted partner for patients and healthcare professionals worldwide.

At Sun Pharma, you’ll find a culture that encourages innovation, rewards performance, and provides limitless opportunities for professional growth.

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Job Role & Responsibilities

As a Regulatory Affairs Executive (ROW), you will:

• Prepare, review, and compile regulatory dossiers for submission in ROW markets such as South Africa, Nepal, and MENA.

• Handle new product registrations, renewals, post-approval variations, and query responses from regulatory authorities.

• Ensure regulatory compliance with applicable guidelines and country-specific requirements.

• Collaborate with cross-functional teams in R&D, QA, and Production to gather documentation for submissions.

• Monitor changes in global regulatory frameworks and update internal teams accordingly.

• Maintain regulatory databases and ensure document lifecycle management.

• Track approval timelines to guarantee on-time product launches.

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Eligibility / Qualifications

• Qualification: M.Pharm (Master of Pharmacy) in Regulatory Affairs, Pharmaceutics, Pharmaceutical Chemistry, or related fields.

  • Relevant courses: M.Pharm in Regulatory Affairs, M.Pharm in Pharmaceutics, PG Diploma in Drug Regulatory Affairs, MSc in Pharmaceutical Sciences.

• Experience: 1–3 years of hands-on experience in Regulatory Affairs for ROW or MENA markets.

• Technical Skills:

  • Expertise in dossier preparation (CTD/eCTD).

  • Strong understanding of regional regulatory frameworks.

  • Knowledge of ICH, WHO, and country-specific guidelines.

  • Proficiency in MS Office and document management systems.

• Soft Skills: Excellent communication, documentation accuracy, and time management skills.

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Location & Salary

• Location: Vadodara, Gujarat, India.

• Salary: Competitive salary package commensurate with experience and company standards.

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Application Process

Interested candidates are encouraged to apply immediately.

Send your updated resume to: Rosemary.varghese@sunpharma.com

Apply before October 25, 2025, to secure your spot!
Early applicants get prioritized for interview shortlisting.

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Why Join Sun Pharma?

• Work with India’s leading pharmaceutical company recognized for global excellence.

• Opportunity to manage international regulatory submissions across emerging markets.

• Exposure to end-to-end regulatory lifecycle management.

• Dynamic and collaborative work environment with continuous learning opportunities.

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Pharma jobs in Vadodara, M.Pharm vacancies, Regulatory Affairs jobs India, Pharmaceutical job openings 2025, Sun Pharma careers, MENA regulatory submissions, high-paying pharma jobs, clinical research and development roles, drug registration process, pharmaceutical regulatory compliance.

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Frequently Asked Questions (FAQs)

1. What is the minimum qualification for the Regulatory Affairs Executive role?
You must hold an M.Pharm degree in Regulatory Affairs or related specialization such as Pharmaceutics or Pharmaceutical Chemistry.

2. How much experience is required for this position?
Candidates with 1–3 years of relevant experience in regulatory submissions or dossier preparation are preferred.

3. Which markets will I work on?
You’ll manage submissions for ROW (Rest of the World) markets, primarily South Africa, Nepal, and the MENA region.

4. Is the role suitable for freshers?
This position is ideal for professionals with some hands-on experience, but motivated freshers with internship experience may also apply.

5. What’s the last date to apply?
Apply before October 25, 2025, to increase your chances of being shortlisted early.

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