Aurobindo Pharma Ltd (APL) stands as a beacon of growth in the pharmaceutical sector, with a remarkable turnover exceeding US$2.8 billion for the fiscal year 2018-19. This Indian multinational company takes pride in its robust presence across more than 34 countries and its impressive portfolio of products exported to 155 nations worldwide. APL has solidified its position as the second-largest generic company based on prescriptions dispensed in the USA, and it ranks among the top 10 generic players in key European markets, including France, Germany, Portugal, the UK, Italy, the Czech Republic, the Netherlands, and Belgium.
As Aurobindo Pharma continues to expand its horizons, we invite talented professionals to join our dynamic team. We are currently hiring for several key positions in our pharmaceutical operations division. Below are the current job openings:
1. Regulatory Affairs (RA) – EU Regulatory Team (OSD)
Qualifications:
- Master of Pharmacy in Pharmaceutics, Pharmaceutical Analysis, Quality Assurance, or Regulatory Affairs
Experience Required:
- 3 to 16 years
Job Responsibilities:
- Manage the life cycle of approved and tentatively approved ANDAs/NDA’s, including the filing of supplements, responses to queries, controlled correspondence, and annual reports.
- Conduct initial submissions and manage product life cycle activities.
- Compile Chemistry, Manufacturing, and Controls (CMC) documentation in accordance with EMEA guidelines.
2. FRD – Cost Improvement Projects (OSD)
Qualifications:
- Master of Pharmacy in Pharmaceutics
Experience Required:
- 3 to 8 years
Job Responsibilities:
- Oversee re-formulation and cost improvement projects to enhance product performance.
- Address nitrosamines and solubility specifications, handle various queries, and adhere to ICH guidelines throughout the complete development process.
- Contribute to the commercial success of product lines through pharmaceutical research and experimentation.
- Apply expertise in laboratory techniques, equipment handling, and GMP standards.
- Scale up from R&D to commercial production while bringing a passion for scientific innovation.
- Possess knowledge of pharmacokinetics and proficiency in bioequivalence studies.
Skills:
- Understanding of regulatory requirements and quality standards in the pharmaceutical domain.
- Excellent problem-solving abilities, critical thinking, and communication skills.
3. Regulatory Affairs Analyst – CMC-SPD (Reviewer)
Qualifications:
- M.Pharmacy or B.Pharmacy
Experience Required:
- 2 to 5 years in US Regulatory Affairs
Job Responsibilities:
- Review Pharmaceutical Development Reports and manufacturing documents, including batch records, yield, and reconciliation summaries.
- Analyze and evaluate analytical documents such as specifications, method validation reports, and stability protocols.
- Prepare and compile ANDA submissions and Annual Reports (ANDAs/NDA).
- Stay updated with ICH and FDA guidelines, ensuring compliance with CTD modules 1, 2, and 3.
How to Apply
If you are passionate about contributing to the pharmaceutical industry and are looking for a challenging yet fulfilling career, we encourage you to apply. Interested candidates can send their resumes via WhatsApp to the following number: 8328053327.
Conclusion
Aurobindo Pharma Ltd is dedicated to fostering a culture of innovation and excellence. By joining our team, you will have the opportunity to work at the forefront of the pharmaceutical industry and make a significant impact in the lives of patients globally. Our commitment to professional growth, as well as competitive compensation and benefits, makes APL a desirable workplace for aspiring professionals.
Explore these opportunities today and take the next step in your career with Aurobindo Pharma Ltd, where you can help shape the future of healthcare.
