Job Description
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Regulatory Consultant (CMC Module 3) in India.
This role is focused on supporting global regulatory activities within the Chemistry, Manufacturing, and Controls (CMC) domain, contributing directly to the lifecycle management of life-saving pharmaceutical products. You will be responsible for authoring and reviewing Module 3 documentation, ensuring regulatory compliance across multiple global markets, and supporting post-approval submissions. Operating in a highly collaborative and science-driven environment, you will work closely with cross-functional teams including manufacturing, QA, QC, and supply chain to ensure accurate and timely regulatory submissions. The position requires strong expertise in EU regulatory frameworks and exposure to US and ROW requirements. You will play a key role in managing variation submissions, site transfers, and regulatory responses to health authority queries. This is an opportunity to contribute to impactful global healthcare programs while working alongside experienced regulatory professionals in a fast-paced, innovation-driven environment.
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Regulatory Consultant (CMC Module 3) in India.
This role is focused on supporting global regulatory activities within the Chemistry, Manufacturing, and Controls (CMC) domain, contributing directly to the lifecycle management of life-saving pharmaceutical products. You will be responsible for authoring and reviewing Module 3 documentation, ensuring regulatory compliance across multiple global markets, and supporting post-approval submissions. Operating in a highly collaborative and science-driven environment, you will work closely with cross-functional teams including manufacturing, QA, QC, and supply chain to ensure accurate and timely regulatory submissions. The position requires strong expertise in EU regulatory frameworks and exposure to US and ROW requirements. You will play a key role in managing variation submissions, site transfers, and regulatory responses to health authority queries. This is an opportunity to contribute to impactful global healthcare programs while working alongside experienced regulatory professionals in a fast-paced, innovation-driven environment.
