Senior 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 Senior Regulatory Affairs Associate based in India.
This role sits at the core of European regulatory operations, ensuring that medicinal product data, submissions, and lifecycle activities are accurately managed and fully compliant with EMA requirements.
You will contribute to the end-to-end regulatory lifecycle, supporting both investigational and authorized products across multiple markets and regulatory systems.
The position involves hands-on execution of regulatory submissions, data validation, and maintenance of critical product information using advanced regulatory platforms.
You will work closely with cross-functional teams to ensure timely, accurate, and compliant delivery of regulatory documentation and updates.
A strong focus is placed on xEVMPD submissions, product lifecycle management, and maintaining data integrity across regulatory databases.
The environment is highly detail-oriented and collaborative, requiring precision, consistency, and a strong understanding of EU regulatory frameworks.
This is a key role for professionals who want to deepen their expertise in regulatory operations and contribute to global healthcare compliance.
Accountabilities:
- Manage and maintain regulatory product data in compliance with EMA guidelines, ensuring accuracy and consistency across systems.
- Perform xEVMPD submissions via EMA Gateway and monitor acknowledgements through relevant regulatory platforms and tools.
- Support Product Lifecycle Management (PLM) activities, including variations, renewals, and updates for both CAPs and non-CAPs.
- Execute Post-Marketing Surveillance (PMS) and Product Update Information (PUI) activities, ensuring timely regulatory compliance.
- Prepare and manage key regulatory deliverables such as eAF, eSMP, SmPC, PIL, and related health authority documentation.
- Handle regulatory procedures including CTA, MAA, IDMP, and lifecycle management processes.
- Utilize Veeva Vault RIM and other regulatory systems for submissions, tracking, and data management activities.
- Ensure data integrity through accurate mapping, aggregation, and consistency across RIMS, DMS, and related platforms.
- Collaborate with internal and cross-functional teams to ensure timely submission delivery and regulatory compliance.
Requirements:
- Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.
- Proven experience in Regulatory Affairs with strong exposure to EMA submissions and xEVMPD processes.
- Hands-on experience with Veeva Vault RIM or similar regulatory information management systems.
- Strong knowledge of EU regulatory frameworks including CTA, MAA, IDMP, and lifecycle management.
- Familiarity with regulatory systems such as RIMS, DMS, and submission tracking tools.
- Proficiency in Microsoft 365 tools, especially Excel, Teams, and SharePoint.
- Strong analytical skills with the ability to interpret and manage complex regulatory data.
- Excellent attention to detail, organization, and documentation accuracy.
- Strong communication and collaboration skills for cross-functional teamwork in a regulated environment.
Benefits:
- Competitive salary package aligned with experience and industry benchmarks
- Opportunity to work in a global regulatory operations environment
- Exposure to EMA processes and advanced regulatory systems (Veeva Vault RIM, xEVMPD, IDMP)
- Career growth in pharmaceutical regulatory affairs and lifecycle management
- Collaborative, cross-functional international work environment
- Structured processes with strong focus on compliance and quality
- Continuous learning opportunities in regulatory frameworks and systems
