Are you ready to advance your career in regulatory affairs with a leading pharmaceutical company? Aurobindo Pharma, a global leader in generic pharmaceuticals, is hiring Regulatory Affairs Professionals for its Formulation R&D team in Hyderabad, focusing on EU markets. This is your chance to contribute to high-impact regulatory submissions and grow in a dynamic, innovative environment. Explore this exciting regulatory affairs job opportunity and take the next step in your pharmaceutical career!
Key Responsibilities
As a Regulatory Affairs Professional at Aurobindo Pharma, you will:
- Prepare and review technical documents for EU filing requirements, including Modules 2 & 3 (Quality Module).
- Interpret and implement EU regulatory guidelines (ICH, EMA) to ensure compliance.
- Manage post-approval variations for EU markets, ensuring seamless regulatory processes.
- Review plant-related documents with a foundational understanding of Quality Assurance (QA).
- Collaborate with cross-functional teams to support formulation R&D and regulatory submissions.
Qualifications
We’re looking for candidates with:
- Educational Background: M. Pharm in Pharmaceutics or Pharmaceutical Analysis.
- Experience: 3–6 years in Formulation R&D (FRD), Formulation Analytical R&D (FARD), or QA, with at least 1 year of hands-on Regulatory Affairs experience in the EU market.
- Technical Skills: Proficiency in preparing and reviewing Module 2 & 3 documents for EU submissions.
- Soft Skills: Strong analytical skills, attention to detail, and ability to work in a fast-paced environment.
Benefits of Joining Aurobindo Pharma
- Career Growth: Opportunities to work on global regulatory submissions and advance in pharmaceutical regulatory affairs.
- Innovative Environment: Be part of a leading organization driving innovation in generic pharmaceuticals.
- Competitive Compensation: Attractive salary package (₹8,00,000–₹12,00,000 per annum, based on experience).
- Work-Life Balance: Supportive work culture with opportunities for professional development.
How to Apply
Ready to make an impact in EU regulatory affairs? Send your updated resume to:
📧 Pooja.Uppalapati@aurobindo.com
Subject Line: “Application for EU Market”
Referrals are welcome! Join Aurobindo Pharma and shape the future of pharmaceutical formulation R&D.
FAQs
Q: What specific experience is required for this role?
A: Candidates need 3–6 years of experience in FRD, FARD, or QA, with at least 1 year in EU regulatory affairs, including hands-on experience with Modules 2 & 3.
Q: What is the application deadline?
A: Applications are accepted until September 25, 2025, or until the position is filled.
