Aurobindo Pharma Ltd (APL) is a leading global pharmaceutical company with a significant presence in the international market. Boasting over US$2.8 billion in revenue (2018-19 figures), APL exports its products to 155 countries and maintains a strong foothold in over 34 nations. Its impressive market standing includes ranking as the second largest generic company by Rx dispensed in the USA and amongst the top 10 generic players in key European markets such as France, Germany, Portugal, the UK, Italy, the Czech Republic, the Netherlands, and Belgium. This rapid growth creates exciting opportunities for talented and ambitious individuals seeking rewarding careers in the pharmaceutical industry. We are currently seeking highly motivated professionals to fill several key positions.
Career Opportunities at Aurobindo Pharma
Aurobindo Pharma offers a dynamic and challenging work environment with ample opportunities for professional growth. Below are details about our current openings:
1. Regulatory Affairs (RA) – EU Regulatory Team (OSD)
- Experience: 3 to 16 years
- Qualifications: Master of Pharmacy (MPharm) in one of the following:
- Pharmaceutics
- Pharmaceutical Analysis
- Quality Assurance/Pharmaceutical Analysis
- Regulatory Affairs
- Job Description: This crucial role within the EU regulatory team focuses on the complete life cycle management of approved and pending ANDAs/NDAs. Responsibilities include:
- Filing supplements (CBE, CBE-30, PAS)
- Responding to regulatory queries
- Managing controlled correspondence
- Preparing and submitting annual reports and updates
- Handling initial submissions and product lifecycle management
- Compiling CMC and EMEA documentation
This position demands a deep understanding of EU regulatory requirements and a proven track record in successful product registration and maintenance. Strong communication and problem-solving skills are essential for effective collaboration with internal and external stakeholders.
2. Formulation Research & Development (FRD) – Cost Improvement Projects (OSD)
- Experience: 3 to 8 years
- Qualifications: MPharm (Pharmaceutics)
- Job Description: This role requires a highly skilled individual with proven experience in cost improvement projects and reformulation strategies. Specific responsibilities include:
- Experience with nitrosamine remediation strategies
- Expertise in solubility specification development and management
- Demonstrated understanding and application of ICH guidelines
- Comprehensive knowledge of the entire drug development process, from initial stages to commercialization
- Proven experience managing numerous products in the commercial stage.
- Proficiency in pharmaceutical research, experimentation, data interpretation based on analytical results.
- Demonstrated expertise in laboratory techniques, equipment handling, and GMP compliance.
- Understanding of scale-up factors from R&D to commercial production.
- Strong formulation development skills and a passion for scientific innovation.
- Essential knowledge of drug pharmacokinetics and Bioequivalence (BE) studies.
- Thorough understanding of regulatory requirements and quality standards in the pharmaceutical industry.
- Excellent problem-solving, critical thinking, and communication skills.
Candidates must demonstrate a strong understanding of pharmaceutical science and a commitment to delivering high-quality results.
3. Regulatory Affairs – CMC & SPD (Reviewer)
- Experience: 2 to 5 years (US Regulatory Affairs)
- Qualifications: MPharm or BPharm
- Job Description: This position requires a detail-oriented individual capable of reviewing complex pharmaceutical documents. Key responsibilities include:
- Reviewing Pharmaceutical Development Reports.
- Reviewing manufacturing documents (batch formulas, manufacturing records, packaging records, yield and reconciliation data, manufacturing summaries, in-process controls data).
- Reviewing analytical documents (specifications, test procedures, method equivalency reports, validation/verification reports, method transfer reports, dissolution protocols, stability protocols, extractable & leachable study reports).
- Preparing, reviewing, and compiling ANDAs for submission.
- Preparing, reviewing, and compiling Annual Reports (ANDAs/NDAs).
- Understanding of ICH and FDA guidelines.
- Knowledge of CTD modules 1, 2, and 3.
This role is ideal for candidates seeking to build their experience in US regulatory affairs within a leading global pharmaceutical company.
How to Apply
Interested and qualified candidates should send their resume to the following WhatsApp number: +91-8328053327. We encourage all applicants to highlight their relevant experience and skills within their resume, showcasing how they meet the specific requirements of the roles described above. We look forward to hearing from you.
