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

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!

Apply now : jobs@loxim.com