About the Role

We are seeking a seasoned pharmaceutical operations leader for our client to head two formulation units (OSD), with strong expertise in tablets, softgel manufacturing, regulatory audits, production, packaging, and regulatory affairs in a CDMO workplace.

The ideal candidate will bring 20–25 years of experience from reputed pharmaceutical organisations and a proven track record of operational excellence and compliance leadership.

Responsibilities

• Lead end‑to‑end operations for two OSD manufacturing units, including production, packaging, and regulatory affairs.
• Oversee softgel manufacturing processes and integrate them within OSD operations.
• Drive operational excellence through lean manufacturing, automation, and productivity initiatives.
• Ensure readiness and successful execution of global regulatory audits (USFDA, MHRA, WHO‑GMP, EU, etc.).
• Provide leadership in regulatory affairs, including submissions, dossier preparation, and lifecycle management.
• Collaborate with QA,



RA, R&D;, engineering, and supply chain teams to achieve business objectives.
• Mentor and build high‑performing teams across operations and regulatory functions.

Qualifications

• Graduate/Postgraduate in Pharmacy.
• 20–25 years of experience in reputed pharmaceutical companies.
• Expertise in OSD operations, softgel manufacturing, regulatory audits, production, packaging, and regulatory affairs.
• Working in a CDMO environment.
• Strong leadership skills with a track record of managing multi‑unit operations.

Required Skills
• GMP & Regulatory Compliance
• Regulatory Affairs & Submissions
• Operations & Production Management
• Audit Management & Regulatory Readiness
• Strategic Planning & Execution
• Team Leadership & Collaboration

Reach out to me on "[email protected]".

📌 Cluster Head Manufacturing (Chennai)
🏢 Solentraaglobal
📍 Chennai