Aurobindo Pharma Hiring for Regulatory Affairs Reviewer (CMC-SPD) for US Market in Hyderabad

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

• Hyderabad, Telangana (likely APL Research Centre-1, Bachupally, based on similar roles)

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!