Sun Pharmaceutical Industries Ltd. (Sun Pharma) is a multinational pharmaceutical powerhouse headquartered in Mumbai, India. As the fourth-largest specialty generic pharmaceutical company worldwide, Sun Pharma operates in over 100 countries, with a strong presence in emerging markets like the ROW (Rest of World) regions. The company specializes in developing, manufacturing, and marketing a wide range of branded and generic formulations, including generics, specialty medicines, and active pharmaceutical ingredients (APIs).
With a commitment to innovation, quality, and patient-centric solutions, Sun Pharma employs over 40,000 professionals globally. In India, it’s renowned for its state-of-the-art facilities and contributions to affordable healthcare. Joining Sun Pharma means being part of a dynamic team that drives regulatory affairs excellence, ensuring products meet international standards. For more on Sun Pharma careers, visit their official site or explore opportunities on platforms like Pharmabharat.org, your go-to hub for pharma jobs in India.
Job Description: Regulatory Affairs Executive – ROW
Sun Pharma is seeking a skilled Regulatory Affairs Executive to support its operations in the ROW markets, with a primary emphasis on South Africa, Nepal, and the MENA regions. This position is based in Vadodara, Gujarat, and requires 1-3 years of hands-on experience in the pharmaceutical industry. The ideal candidate will play a pivotal role in navigating complex regulatory frameworks, ensuring seamless product launches, and maintaining compliance across diverse international markets.
Key Responsibilities:
- Prepare and submit regulatory dossiers for new product registrations, renewals, variations, and amendments in ROW markets, including South Africa, Nepal, and MENA countries.
- Handle query responses from regulatory authorities, ensuring timely resolutions to avoid delays in approvals.
- Manage the full life cycle of pharmaceutical products, from initial filing to post-approval changes, with a focus on dossier preparation for MENA markets.
- Stay updated on evolving regulatory timelines and guidelines in target regions to facilitate efficient approvals and market access.
- Collaborate with cross-functional teams, including R&D, quality assurance, and marketing, to align regulatory submissions with business objectives.
- Conduct gap analyses and ensure compliance with international standards like WHO, ICH, and region-specific requirements.
This regulatory affairs job demands a proactive approach to problem-solving and a deep understanding of global pharma regulations. Vadodara’s strategic location near Sun Pharma’s manufacturing hubs makes it an ideal base for this role, offering exposure to cutting-edge pharma regulatory affairs practices.
Qualifications and Experience:
- Educational Requirement: M.Pharm or equivalent in Pharmaceutical Sciences.
- Experience: 1-3 years in regulatory affairs within the pharmaceutical sector, preferably with exposure to ROW or emerging markets.
- Skills: Strong knowledge of dossier preparation, CTD/eCTD formats, and tools like Veeva or similar regulatory software. Excellent communication skills for handling international queries.
- Preferred: Prior experience in MENA regulatory submissions or life cycle management.
Sun Pharma offers competitive salaries, professional growth opportunities, and a collaborative work environment. This pharma job in Vadodara is perfect for M.Pharm graduates looking to advance in regulatory affairs careers.
How to Apply for This Regulatory Affairs Executive Position
Ready to take your regulatory affairs expertise to Sun Pharma? Applying is simple and straightforward. Submit your updated resume highlighting your experience in regulatory submissions, dossier preparation, and ROW markets.
- Email Your Resume: Send it to Rosemary.varghese@sunpharma.com with the subject line: “Application for Regulatory Affairs Executive – ROW, Vadodara”.
- Include: A cover letter detailing your relevant experience in South Africa, Nepal, MENA regions, or similar markets.
- Deadline: Applications are reviewed on a rolling basis—apply soon to stay ahead!