Regulatory Affairs Associate

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 opportunity to contribute to the continued availability and compliance of medicinal products in a collaborative, international life sciences environment.

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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1