Sun Hiring Regulatory Affairs

MPharm Regulatory Affairs Jobs | Sun Pharma Baroda

M.Pharm Regulatory Affairs vacancies in Baroda with 2–5 years experience. Work on USFDA submissions, CTD/eCTD dossiers.

Sun Pharmaceutical Industries Limited is hiring experienced professionals for the Regulatory Affairs (US Regulatory Group) function at its Baroda (Vadodara) location. This opportunity is designed for candidates with strong expertise in pharmaceutical regulatory documentation, submission preparation, and compliance with international regulatory frameworks such as USFDA, ICH, and EU guidelines.

Regulatory Affairs professionals play a vital role in the pharmaceutical industry. They ensure that medicines developed by pharmaceutical companies meet strict regulatory standards before being approved for global markets. From preparing regulatory submissions to managing post‑approval changes and responding to regulatory queries, regulatory professionals act as a bridge between pharmaceutical companies and global regulatory authorities.

This role is particularly suited for professionals who have experience in preparing regulatory dossiers such as CTD and eCTD submissions for ANDA, NDA, and MAA filings. Candidates who want to build long‑term careers in global pharmaceutical regulatory affairs, drug registration, and regulatory compliance will find this opportunity highly valuable.

Company Overview

Sun Pharmaceutical Industries Limited is one of the world’s largest specialty generic pharmaceutical companies and a global leader in pharmaceutical manufacturing, research, and regulatory compliance. Headquartered in India, the company operates in more than 100 countries and supplies high‑quality medicines to healthcare systems across global markets.

Sun Pharma focuses on developing and manufacturing complex generics, specialty medicines, active pharmaceutical ingredients, and innovative therapies. The company operates multiple USFDA‑approved manufacturing facilities and research centers that follow strict international regulatory standards including USFDA, EMA, WHO‑GMP, and ICH regulatory frameworks.

The Regulatory Affairs teams within Sun Pharma play a critical role in ensuring that pharmaceutical products are successfully registered and approved across international markets. These teams coordinate with research and development, manufacturing, quality assurance, and contract development organizations to prepare and submit regulatory dossiers for global approvals.

Working at Sun Pharma provides professionals with exposure to global pharmaceutical regulatory processes, complex drug approval systems, and advanced regulatory documentation practices used in the international pharmaceutical industry.

Job Role & Responsibilities

The Regulatory Affairs professional will support the preparation, compilation, and submission of pharmaceutical regulatory dossiers while ensuring compliance with international regulatory guidelines.

Regulatory Submission Preparation

Regulatory Affairs professionals prepare detailed documentation required for pharmaceutical product approval.

Key responsibilities include:

• Preparing and compiling regulatory dossiers such as CTD and eCTD submissions
• Supporting regulatory filings for ANDA, NDA, and MAA applications
• Preparing documentation for post‑approval variations and regulatory updates
• Ensuring submission documents comply with regulatory guidelines

These submissions are essential for obtaining regulatory approvals from global health authorities.

Compliance with Global Regulatory Guidelines

Pharmaceutical regulatory professionals ensure that product documentation aligns with international standards.

Key responsibilities include:

• Ensuring compliance with USFDA, ICH, EU, and Indian regulatory guidelines
• Monitoring regulatory changes and guideline updates
• Maintaining documentation according to regulatory submission requirements

Maintaining regulatory compliance ensures that pharmaceutical companies can successfully launch products in international markets.

Regulatory Strategy Support

Regulatory teams help define submission strategies for new pharmaceutical products.

Key responsibilities include:

• Supporting regulatory strategy development for product registrations
• Identifying regulatory pathways for global market approvals
• Ensuring regulatory documentation supports product development plans

Strategic regulatory planning helps pharmaceutical companies accelerate product approvals in global markets.

Cross‑Functional Coordination

Regulatory Affairs teams work closely with multiple departments involved in drug development and manufacturing.

Key responsibilities include:

• Coordinating with R&D teams for product development documentation
• Working with CDMO partners for regulatory submission requirements
• Collaborating with manufacturing teams for regulatory data generation
• Coordinating with Quality Assurance teams for compliance documentation

Cross‑functional collaboration ensures that all regulatory submissions are accurate, complete, and compliant.

Regulatory Query Response and Tracking

Regulatory authorities often request clarifications or additional documentation during the review process.

Key responsibilities include:

• Responding to deficiency letters and regulatory queries
• Preparing responses to regulatory agency questions
• Maintaining regulatory submission databases
• Tracking submission timelines, approvals, and regulatory milestones

Efficient regulatory communication helps pharmaceutical companies maintain successful product registrations worldwide.

Eligibility / Qualifications

Sun Pharma is looking for candidates with academic backgrounds in pharmaceutical sciences and experience in regulatory affairs documentation.

Required Educational Background

M.Pharm (Pharmaceutics, Pharmaceutical Analysis, Regulatory Affairs), M.Pharm Quality Assurance, M.Pharm Industrial Pharmacy

Candidates with strong knowledge of pharmaceutical regulatory guidelines and submission documentation practices will be preferred.

Experience Requirement

2 to 5 years of experience in pharmaceutical regulatory affairs.

Relevant experience may include:

• Preparation of CTD/eCTD dossiers
• ANDA or NDA regulatory submissions
• Regulatory documentation review
• Regulatory authority communication

Candidates with experience working with USFDA submission systems will have an advantage.

Preferred Candidate Skills

Ideal candidates should demonstrate:

• Strong understanding of pharmaceutical regulatory frameworks
• Experience with CTD/eCTD submission formats
• Knowledge of USFDA, ICH, and EU regulatory guidelines
• Ability to coordinate with cross‑functional teams
• Strong documentation and communication skills

Professionals with experience in global regulatory submissions will be highly valued.

Location & Salary

Job Location

Sun Pharmaceutical Industries Limited

Baroda (Vadodara)
Gujarat, India

Vadodara is one of India’s major pharmaceutical manufacturing and research hubs and hosts several multinational pharmaceutical companies.

Salary

Compensation for Regulatory Affairs professionals typically depends on candidate experience, regulatory expertise, and previous exposure to global submission processes. Candidates with strong experience in US regulatory submissions often receive competitive industry packages.

Application Process

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

Send your CV to:

Rosemary.varghese@sunpharma.com

Applicants should include the following information in their application:

• Current CTC
• Expected CTC
• Notice period

Candidates are encouraged to highlight their experience with regulatory dossier preparation, CTD/eCTD submissions, and regulatory compliance in their resume.

Why Build a Career in Regulatory Affairs

Regulatory Affairs is one of the most important functions in the pharmaceutical industry. Regulatory professionals ensure that medicines developed by pharmaceutical companies meet strict safety, efficacy, and quality standards before they are approved for public use.

Professionals working in regulatory affairs gain expertise in global regulatory guidelines, pharmaceutical documentation systems, and international drug approval processes. These skills are highly valuable across pharmaceutical companies, biotechnology firms, and regulatory consulting organizations.

Typical career progression may include:

• Regulatory Affairs Executive
• Senior Regulatory Affairs Specialist
• Global Regulatory Manager
• Regulatory Compliance Director
• Head of Regulatory Affairs

As pharmaceutical companies expand into international markets, professionals with expertise in USFDA submissions and global regulatory compliance remain in high demand.

Frequently Asked Questions (FAQs)

Who can apply for the Sun Pharma Regulatory Affairs role?

Candidates with an M.Pharm qualification and 2–5 years of regulatory affairs experience can apply.

What regulatory submissions will candidates work on?

Professionals may work on CTD/eCTD submissions for ANDA, NDA, and MAA applications.

Which regulatory authorities are relevant for this role?

The role requires knowledge of regulatory guidelines from USFDA, ICH, EU authorities, and Indian regulatory agencies.

Where is the job located?

The position is based in Baroda (Vadodara), Gujarat.

How can candidates apply?

Applicants can send their updated resume to the official recruitment email mentioned in the job announcement.

Job Summary

Company	Sun Pharmaceutical Industries Limited
Vacancies	Regulatory Affairs Executive
Required Education	MPharm Pharmaceutics, MPharm Regulatory Affairs, MPharm Pharmaceutical Analysis
Experience	2–5 Years