Head – FDA Products

Job Title: Head FDA Products

Company: Our Client (Leading Pharmaceutical Manufacturer)

Location: Gurgaon (WFO)

CTC: 2540 LPA

Employment Type: Full-time

About Antal

Antal International, East Patel Nagar Delhi, is a leading recruitment consultancy having expertise in connecting top talent across IT, Manufacturing and FMCG industries with leading organizations

About the Role

Our Client is setting up a new pharmaceutical manufacturing facility in Kutch, Gujarat. We are looking for an experienced Head FDA Products to lead the technical setup, regulatory readiness, and overall operations of the plant.

Key Responsibilities

• Set up and optimize manufacturing lines for APIs, oral formulations, injectables, and biopharmaceuticals .
• Implement advanced, scalable technologies and ensure strong cGMP compliance.
• Lead process development, scale-up, and validation activities.
• Drive specialty products including oncology, hormones, steroids, and high-value injectables .
• Establish GMP documentation and prepare the site for WHO / USFDA audits.
• Support dossier development and WHO PQ submissions.
• Mentor Production, QA, QC, and Engineering teams.

Qualifications

• M.Pharm / B.Pharm / Ph.D. in Pharma Sciences, Chemistry, or related field.

Experience

• 2025 years in WHO-GMP pharmaceutical manufacturing.
• Strong hands-on background in APIs, injectables, formulations, excipients, and biopharmaceuticals .
• Experience in plant setup, validation, scale-up, and regulatory inspections .
• Strong understanding of WHO/USFDA/EU guidelines and technical documentation.
• Proven leadership and ability to drive compliance and operational excellence.