Are you passionate about advancing your career in pharmaceutical regulatory affairs? Sun Pharmaceutical Industries Ltd, a global leader in generics and specialty pharmaceuticals, is hiring a Regulatory Affairs Executive in Baroda, India. This role offers a unique opportunity to contribute to US and EU regulatory filings, labeling, and product launches, ensuring compliance with stringent FDA standards. If you’re skilled in regulatory submissions and thrive in dynamic, cross-functional teams, this position at Sun Pharma could be your next career milestone.
Responsibilities
As a Regulatory Affairs Executive at Sun Pharma, you will play a pivotal role in ensuring compliance and supporting product launches. Your key responsibilities include:
- Preparing and Reviewing Labeling: Develop and review labeling for ANDA and NDA applications, ensuring compliance with US FDA regulations and guidelines.
- Structured Product Labeling (SPL): Create and manage SPL for FDA drug listings, maintaining accuracy and regulatory adherence.
- Cross-Functional Coordination: Collaborate with R&D, quality assurance, and marketing teams to implement labeling updates and ensure timely, compliant product launches.
- Regulatory Submissions: Manage regulatory filings and submissions, including final labeling artwork, using specialized software tools.
- Third-Party Liaison: Work with private label distributors and third parties to meet labeling requirements, including Risk Evaluation and Mitigation Strategies (REMS) when applicable.
Qualifications
To excel in this role, you should bring the following qualifications and skills:
- Education: B.Pharm, M.Sc or M.Pharm in Pharmacy or a related field.
- Experience: Several years of experience in regulatory affairs, with a focus on labeling and submissions for US, EU, or other regulated markets.
- Regulatory Knowledge: Strong understanding of US FDA labeling standards, product launch processes, and regulatory compliance requirements.
- Skills: Excellent coordination, communication, and organizational skills to manage internal and external stakeholders effectively.
- Technical Proficiency: Familiarity with regulatory software tools for submission and artwork management.
Benefits
Joining Sun Pharma offers a range of benefits, including:
- Career Growth: Opportunities to work on global regulatory projects, enhancing your expertise in US and EU markets.
- Collaborative Environment: Work with cross-functional teams in a dynamic, innovative setting.
- Competitive Compensation: Attractive salary package with additional benefits like health insurance and professional development programs.
- Industry Leadership: Be part of one of India’s top pharmaceutical companies, known for its commitment to quality and innovation.
How to Apply
Ready to take the next step in your regulatory affairs career? Apply now through the official Sun Pharma careers portal: Apply Here. Submit your updated resume and a cover letter highlighting your experience in regulatory filings and labeling. Applications are reviewed on a rolling basis, so don’t wait—apply by October 29, 2025, to be considered.
FAQs
Q: What is the primary focus of the Regulatory Affairs Executive role at Sun Pharma?
A: The role focuses on preparing and reviewing labeling for ANDA/NDA applications, managing FDA-compliant submissions, and coordinating with teams for product launches.
Q: Is experience with US FDA regulations mandatory for this position?
A: Yes, a strong understanding of US FDA labeling standards and regulatory requirements is essential, along with experience in US/EU submissions.
