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 environment.

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.
- Robust 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