Regulatory Affairs Associate- Local Regulatory Affairs Operations

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 – Local Regulatory Affairs Operations based in India.

This role sits at the heart of post-approval regulatory operations, ensuring that life sciences products remain compliant, accessible, and up to date across local and regional markets. You will play a key part in managing regulatory lifecycle activities such as variations, renewals, and marketing authorization maintenance. The position involves close collaboration with cross-functional teams including regulatory, safety, CMC, and operations stakeholders. You will contribute directly to the timely submission of regulatory documents and communication with health authorities. The environment is highly detail-oriented, structured, and quality-driven, requiring precision and accountability. This role offers strong exposure to global regulatory frameworks and post-approval processes within the pharmaceutical industry. It is ideal for someone who wants to contribute meaningfully to patient access through compliant and efficient regulatory execution.

In this role, you will be responsible for supporting end-to-end local regulatory operations and ensuring compliance across post-approval product lifecycle activities.

• Manage regulatory submissions including variations (minor/major), renewals, MA transfers, withdrawals, and responses to health authority queries
• Support preparation and coordination of Module 1 activities covering CMC, safety, administrative updates, and post-approval changes
• Assist in handling country-specific regulatory requirements, including submissions through health authority portals
• Contribute to DHCP communications and follow-up on regulatory commitments
• Maintain and update regulatory information using systems such as RIMS and Veeva Vault
• Support linguistic reviews, translation coordination, readability testing, and artwork/mock-up approvals
• Assist in promotional material review, including product information updates and regulatory review processes
• Support PSUR submissions and regulatory intelligence activities at the country level

Requirements:

The ideal candidate has experience in regulatory affairs operations, particularly in post-approval lifecycle management within the pharmaceutical or life sciences industry.

• 2+ years of experience in regulatory affairs, including submissions such as MAAs, variations, renewals, and lifecycle management activities
• Working knowledge of EU regulatory procedures, including centralized procedure coordination
• Familiarity with post-approval regulatory documentation such as Module 1, CMC, safety updates, and administrative submissions
• Experience working with regulatory systems such as Veeva Vault, RIMS, or similar platforms
• Understanding of health authority portals and submission processes
• Exposure to PSUR preparation, regulatory intelligence, and compliance monitoring
• Strong attention to detail with excellent organizational and documentation skills
• Good communication skills and ability to collaborate with cross-functional teams
• Ability to manage multiple regulatory tasks in a deadline-driven environment
• Bachelor’s degree in Pharmacy, Life Sciences, Pharmaceutical Sciences, or related field

Benefits:

• Competitive salary aligned with experience in regulatory affairs operations
• Opportunity to work in a global clinical research and life sciences environment
• Exposure to international regulatory frameworks and post-approval lifecycle management
• Remote or hybrid flexibility depending on project requirements in India
• Career development opportunities within regulatory and clinical operations domains
• Structured learning environment with strong cross-functional collaboration
• Contribution to meaningful healthcare outcomes and patient access to treatments