This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Associate based in India.
Join a regulatory affairs team supporting the lifecycle management of medicinal products across European markets. In this role, you will contribute to post-approval regulatory activities, helping ensure products remain compliant throughout their lifecycle. You will assess the regulatory impact of manufacturing, quality, labeling, and product-information changes and support the development of appropriate regulatory strategies. The position combines regulatory expertise, CMC documentation, dossier management, and cross-functional collaboration. You will work with established regulatory systems and processes while helping identify and resolve documentation gaps and compliance risks. This is an chance to contribute to the continued availability and compliance of medicinal products in a collaborative, international life sciences environment.
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Accountabilities
Conduct Regulatory Impact Assessments (RIA)



for change controls and evaluate the regulatory implications of manufacturing, quality, labeling, and product-information changes.
Maintain and manage regulatory change records and related activities within Veeva RIMS.
Support the development and implementation of regulatory strategies for post-approval changes across applicable markets.
Review, update, and author Module 3 sections of Common Technical Document (CTD) dossiers for medicinal products.
Ensure CMC documentation remains accurate, current, complete, and aligned with applicable regulatory expectations.
Support dossier lifecycle management and maintenance activities across multiple European markets.
Conduct detailed gap analyses of Module 3 documentation to identify compliance risks, data gaps, and documentation deficiencies.
Develop and recommend appropriate remediation plans and regulatory strategies to address identified gaps.
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📌 Regulatory Affairs Associate (India)
🏢 Jobgether
📍 India