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 Senior Regulatory Affairs Associate role is a key contributor position focused on supporting global regulatory lifecycle management across major international markets, including the EU, US, and other regulated regions.
You will be responsible for ensuring the timely preparation, coordination, and delivery of high-quality regulatory submissions that support global drug development and lifecycle activities.
The role involves close collaboration with cross-functional teams to manage submission packages, post-approval changes, and regulatory authority interactions.
You will contribute to regulatory strategy execution while ensuring compliance with global regulatory standards and internal quality expectations.
A strong focus is placed on accuracy, coordination, and responsiveness in handling Health Authority queries and regulatory documentation.
You will also support audit readiness, compliance activities, and safety-related regulatory reporting.
This role is ideal for regulatory professionals who want to grow within a global, impact-driven, and detail-oriented environment.

• Support global regulatory lifecycle management activities across EU, US, and other international markets.
• Contribute to the preparation and execution of regulatory strategies for global and regional submissions.
• Prepare, coordinate, and deliver regulatory submission packages (Modules 1–5) in compliance with applicable requirements.
• Manage post-approval changes, variation submissions, and lifecycle maintenance activities.
• Handle Health Authority queries and ensure timely, accurate responses in collaboration with internal stakeholders.
• Provide submission planning and coordination support, including tracking timelines and deliverables.
• Maintain accurate regulatory documentation and records within Regulatory Information Management (RIM) systems.
• Support safety-related regulatory activities, including aggregate reports and urgent safety updates.
• Assist with audit preparation, compliance activities, and inspection readiness initiatives.

Requirements:

• 5–8 years of experience in Regulatory Affairs within pharmaceutical, biotech, or life sciences organizations.
• Strong understanding of EU and US regulatory requirements, submission processes, and post-approval obligations.
• Experience in global regulatory submissions and lifecycle management activities.
• Solid knowledge of regulatory documentation standards and compliance frameworks.
• Experience coordinating with cross-functional teams and managing stakeholder communications.
• Strong organizational, planning, and time management skills in a fast-paced environment.
• Educational background in B.Sc., M.Sc., B.Pharmacy, or M.Pharmacy.
• Excellent attention to detail and strong communication skills.

Benefits:

• Competitive compensation aligned with regulatory experience and expertise.
• Opportunity to contribute to global healthcare and patient-impacting therapies.
• Exposure to international regulatory environments, including EU and US markets.
• Collaborative and mission-driven work culture focused on quality and compliance.
• Strong career development and progression opportunities in regulatory affairs.
• Involvement in end-to-end regulatory lifecycle activities across global programs.
• Continuous learning and exposure to evolving global regulatory standards.