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Join Aurobindo Pharma, a leading Indian pharmaceutical company committed to healthier lives, for a role in Regulatory Affairs at our Hyderabad facility. We’re hiring a Reviewer for Chemistry, Manufacturing, and Controls (CMC) in the Sterile Product Division (SPD), focusing on topical and dermatological products for the US market.
Job Details: Reviewer-CMC-SPD (Regulatory Affairs)
We’re seeking professionals with 2-5 years of experience in regulatory affairs for US market submissions, specifically for topical and derma products. Immediate joiners with expertise in CMC documentation are preferred.
Position
- Reviewer – CMC-SPD (Regulatory Affairs)
Department
- Regulatory Affairs (US Market)
Qualification
- M.Pharm (Pharmaceutics, Regulatory Affairs, or related specialization)
Experience
- 2-5 years in Regulatory Affairs for US topical and dermatological products
Key Responsibilities
- Review and compile ANDA/NDA submissions, focusing on Module 2 and 3 for topical/derma products
- Ensure compliance with FDA guidelines and eCTD requirements
- Evaluate CMC documents for sterile and topical formulations, including stability data and manufacturing processes
- Handle post-approval activities, such as CBE, CBE-30, and PAS submissions
- Collaborate with cross-functional teams (R&D, QA, QC) to address regulatory queries
- Maintain audit-ready documentation and support FDA inspections
Key Skills
- Expertise in CMC documentation for topical/derma products
- Knowledge of GMP and FDA regulatory requirements
- Proficiency in eCTD systems and Module 3 preparation
- Strong analytical and problem-solving skills
- Excellent communication and coordination abilities
Job Location
Why Join Aurobindo Pharma?
Aurobindo Pharma, headquartered in Hyderabad, is a top-tier multinational with a USD 2.8 billion turnover, exporting to 150+ countries. With USFDA and EUGMP approvals, our robust R&D and rapid DMF filings drive global healthcare innovation.
Key Benefits
- Work in a USFDA-compliant, cutting-edge research facility
- Gain exposure to international regulatory processes
- Collaborate with experienced regulatory professionals
- Opportunities for career growth in a leading pharma firm
How to Apply
Interested candidates should:
- Send updated CV to sreeja.yangam@aurobindo.com with subject “Reviewer-CMC-SPD Application”
- Scan the QR code from the official announcement for the detailed job description
- Include experience letters, payslips, and educational certificates
- Be prepared to discuss CMC for topical products and FDA submission processes
- Note: Aurobindo Pharma does not request sensitive information (e.g., SSN, bank details) during recruitment. Verify communications via official @aurobindo.com emails.
About Aurobindo Pharma
Founded in 1986, Aurobindo Pharma is a global leader in generic pharmaceuticals and APIs, with 26 manufacturing facilities and a diverse portfolio across 35+ therapeutic areas. Our inclusive culture fosters continuous learning and innovation. Visit www.aurobindo.com.
Our Mission
- Make affordable, high-quality medicines accessible globally
- Drive innovation through robust R&D
- Foster an inclusive, growth-oriented workplace
Apply now by emailing sreeja.yangam@aurobindo.com or scanning the QR code to join Aurobindo Pharma in Hyderabad. Contribute to healthier lives through regulatory excellence!