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This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Global Regulatory Lead Partner based in India.
This is a high-impact global regulatory affairs role focused on leading lifecycle management and regulatory strategy execution for assigned pharmaceutical products across major international markets. You will act as the primary regulatory point of contact for designated portfolios, ensuring compliant, timely, and high-quality submissions across the US, EU, and other regulated regions. The role requires close collaboration with cross-functional teams including clinical, safety, CMC, labeling, and regulatory operations to drive alignment across the product lifecycle. You will be responsible for shaping regulatory approaches, managing health authority interactions, and ensuring continued market authorization of established products. This position sits at the intersection of regulatory science and strategic execution, requiring both deep technical expertise and strong leadership in a global matrix environment. The environment is fast-paced, highly collaborative, and mission-driven, with a strong focus on delivering life-enhancing therapies to patients worldwide.
Accountabilities:
- Serve as the global regulatory lead for assigned products, ensuring maintenance of registrations across key markets including the US and EU.
- Lead regulatory lifecycle management activities, including strategy development, submission planning, timelines, prioritization, and risk assessment.
- Manage end-to-end regulatory submissions and health authority interactions, including responses to queries, labeling negotiations, and ongoing regulatory correspondence.
- Coordinate with subject matter experts to develop and execute response strategies for regulatory authority requests and commitments.
- Support global labeling activities including CCDS, USPI, SmPC, and country-specific label updates and submissions.
- Provide regulatory input for periodic safety reports, annual reports, renewals, and other post-approval documentation.
- Conduct regulatory assessments for tender submissions, product variations, and market-specific registration changes or deletions.
- Ensure timely execution of agency commitments while maintaining compliance with global regulatory standards and guidelines.
- Perform regulatory intelligence activities, including review of global guidelines, competitor landscape, and emerging regulatory trends.
- Collaborate closely with cross-functional teams to ensure alignment and successful execution of global regulatory strategies.
Requirements:
- Bachelor’s degree or higher in Pharmaceutical Sciences, Chemistry, Regulatory Affairs, or a related discipline.
- 5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, including exposure to major health authorities.
- Proven experience leading regulatory activities across multiple geographic regions, ideally covering both small molecules and biologics.
- Strong understanding of global drug development processes, regulatory frameworks, and post-approval lifecycle management.
- Experience interacting directly with health authorities and leading responses to regulatory questions and submissions.
- Strong ability to develop and execute global regulatory strategies balancing risk, timelines, and business priorities.
- Excellent written and verbal communication skills with experience in cross-functional and stakeholder management.
- Strong analytical, organizational, and project management capabilities with high attention to detail.
- Good knowledge of ICH guidelines and global regulatory filing requirements.
- Ability to work independently, manage multiple priorities, and perform effectively in a fast-paced environment.
Benefits:
- Competitive compensation aligned with global regulatory leadership roles.
- Opportunity to work on life-enhancing pharmaceutical products with global regulatory impact.
- Exposure to international regulatory agencies and complex multi-region product portfolios.
- Flexible and collaborative remote work environment within India.
- Strong focus on learning, professional development, and regulatory expertise growth.
- Inclusive, mission-driven culture focused on innovation, quality, and patient impact.
- Opportunity to contribute to high-visibility regulatory strategy and global lifecycle management initiatives.
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