GM – Quality & Regulatory Affairs (Pharmaceutical API & Intermediate)

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About LOXIM

LOXIM INDUSTRIES LIMITED

The Role

General Manager – Quality & Regulatory Affairs

Key Responsibilities

• Lead QA, QC, Regulatory Affairs, and Compliance functions across all manufacturing sites.
• Maintain full alignment with cGMP, ICH Q7, and international quality standards.
• Strengthen the Quality Management System (QMS) with robust processes for deviation, CAPA, and change control.
• Manage DMF, CEP, and global regulatory submissions, renewals, and customer documentation.
• Lead regulatory, customer, and internal audits, ensuring timely and effective compliance actions.
• Collaborate with R&D, Technology Transfer, and Manufacturing teams for process validation and scale-up readiness.
• Drive continuous improvement initiatives and digitalization in quality systems.
• Build, guide, and empower a high-performing Quality & Regulatory team with strong ownership and accountability.
• Represent the company before regulatory bodies, partners, and customers to reinforce trust and compliance.

Skills and Knowledge

• Proven exposure to USFDA / EMA / PMDA / WHO inspections.
• Hands-on experience in handling regulatory audits, submissions, and correspondence with global health authorities
• Experience in greenfield setups, multi-product facilities, and contract manufacturing (CMO/CDMO) environments is an advantage.
• Strategic thinker who balances compliance with business agility.
• Strong leadership and communication skills with a passion for quality excellence.

Do you thrive in a fast-paced environment where precision, compliance, and innovation intersect?

If so, we’d love to meet you!

jobs@loxim.com