Job Description

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.
• Support post-approval regulatory activities throughout the product lifecycle and contribute to the maintenance of marketing authorizations.
• Collaborate with regulatory, quality, manufacturing, and other cross-functional stakeholders to ensure regulatory commitments and submissions are delivered accurately and on time.
• Maintain a strong focus on regulatory compliance, documentation quality, traceability, and adherence to established processes.

Requirements:

• At least 3 years of relevant experience in regulatory affairs, particularly in post-approval regulatory activities for medicinal products.
• Demonstrated experience working with products registered through European regulatory procedures, including Centralized Procedure (CP), Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP), and National Procedures.
• Practical knowledge of post-approval lifecycle management and maintenance of marketing authorizations across European markets.
• Experience assessing regulatory impacts associated with manufacturing, quality, labeling, and product-information changes.
• Strong understanding of CMC documentation and experience reviewing or authoring Module 3 sections of CTD dossiers.
• Familiarity with regulatory information management systems, particularly Veeva RIMS, is highly desirable.
• Experience performing regulatory gap analyses, identifying compliance risks, and developing remediation approaches.
• Strong attention to detail and the ability to manage complex documentation while maintaining accuracy and consistency.
• Good understanding of applicable regulatory requirements and the ability to translate regulatory expectations into practical strategies.
• Strong organizational and project-management skills, with the ability to manage multiple activities and deadlines across different markets.
• Effective communication and collaboration skills, with the ability to work confidently with cross-functional and international stakeholders.
• A proactive, analytical, and solutions-oriented approach to regulatory challenges.

Benefits:

• Opportunity to contribute to the regulatory lifecycle of medicinal products and support access to important healthcare therapies.
• Exposure to European regulatory procedures and post-approval lifecycle management across multiple markets.
• Opportunity to develop expertise in CMC documentation, CTD dossiers, regulatory impact assessments, and regulatory information management.
• Collaboration with multidisciplinary and international teams across the life sciences and healthcare environment.
• Remote-work flexibility available for eligible India-based locations.
• Opportunities for professional development and continued growth within regulatory affairs and the broader life sciences sector.
• Full-time employment with a competitive compensation and benefits package, subject to the applicable employment terms.
• Work in a purpose-driven environment focused on quality, compliance, and meaningful impact on healthcare.