GM – Quality & Regulatory Affairs - Pharmaceutical API & Intermediate

Title : GM – Quality & Regulatory Affairs - Pharmaceutical API & Intermediate

Location : Ahmedabad, Gujarat

Experience : >

15 years in API Quality & Regulatory roles, including leadership positions

Education : M. Pharm / M.Sc. (Chemistry or Pharmaceutical Sciences); Ph.D preferred

About LOXIM

Founded in 1977, LOXIM has been at the forefront of combining chemistry with strategic business expertise to deliver high-quality solutions for global markets. Our portfolio spans APIs, Intermediates, KSM, and CMO / CDMO capabilities within the pharmaceutical industry, Dyes and Engineering Plastics.

Headquartered in India , we operate across Singapore, Japan, Indonesia, Vietnam, Thailand, USA, Canada, Mexico, Honduras, Brazil, Colombia, Switzerland, Germany, Italy, Spain, France, Poland, and the Netherlands , ensuring seamless service and collaboration worldwide.

The Role

The General Manager – Quality & Regulatory Affairs will lead our Quality and Regulatory department of our API and Intermediate business with a strong focus on quality, compliance, and global regulatory excellence. This role calls for a hands-on leader who can ensure alignment with cGMP, ICH, and international regulatory standards while strengthening systems, people, and culture. The ideal candidate brings deep understanding of API and intermediate processes, global filing requirements such as DMF and CEP, and the ability to guide teams through complex audits, inspections, and technology transfers with confidence and integrity

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

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

If so, we’d love to meet you!

Apply now : jobs@loxim.com