Regulatory Consultant (CMC Module 3) in India at Jobgether

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.

• Author and review CMC Module 3 documentation for post-approval submissions and lifecycle management activities across global markets.
• Prepare and manage regulatory variation submissions including EU (Type IA, IB, II), US (CBE, PAS), and ROW regulatory requirements.
• Support site transfer activities by coordinating documentation, regulatory strategy inputs, and cross-functional alignment.
• Collaborate with manufacturing, QA, QC, and supply chain teams to ensure accuracy, completeness, and compliance of regulatory data.
• Track, manage, and deliver assigned regulatory activities within defined timelines and regulatory expectations.
• Respond to health authority queries and deficiency letters, ensuring timely, accurate, and compliant resolutions.
• Participate in cross-functional and client meetings as a regulatory subject matter expert and provide technical guidance to internal teams.
• Ensure adherence to regulatory standards, project scope, and submission timelines while maintaining high-quality deliverables.

• 6–12 years of experience in Regulatory Affairs with strong expertise in CMC Module 3 authoring and review.
• Hands-on experience in post-approval lifecycle management, including variations and global submissions.
• Strong knowledge of EU regulatory requirements, with exposure to US and ROW regulatory frameworks.
• Experience in API and Drug Product (DP) regulatory submissions and lifecycle activities.
• Familiarity with eCTD submission standards and regulatory documentation tools.
• Strong analytical, problem-solving, and documentation skills with attention to regulatory detail.
• Excellent communication and stakeholder management abilities across global, cross-functional teams.
• Ability to work independently, manage multiple priorities, and deliver under tight regulatory timelines.
• Master’s degree (M.Pharm / M.Sc. or equivalent) in Life Sciences or related field.

• Remote or hybrid work flexibility depending on assignment.
• Opportunity to work on global regulatory submissions impacting approved pharmaceutical products worldwide.
• Exposure to leading-edge CMC regulatory strategies and international health authority interactions.
• Collaborative, science-driven environment with strong cross-functional engagement.
• Career development within a global life sciences organization.
• Competitive compensation and comprehensive employee benefits (as per company policy).