Executive Regulatory Affairs

At Keuro Life, we are committed to transforming healthcare by blending cutting-edge science, scalable innovation, and human-centric values. With a strong foundation in pharmaceutical R&D, biologics, and next-generation therapies, we aim to make high-quality, affordable treatments accessible across the globe.

Driven by a deep sense of purpose and precision, our portfolio spans general medicine, oncology, immunology, hormones, and biosimilars—delivering excellence across the spectrum of care. From state-of-the-art manufacturing facilities to a paperless, fully digitized operations model, we ensure every product meets the highest global standards of quality and compliance.

Our people-first culture, combined with a relentless pursuit of innovation, positions Keuro Life as a new-age leader in health science—one that’s as agile as it is ethical, as bold as it is reliable.

Company Website: https://www.keuro.life/eng-backup-old/

Job Description:

The ideal candidate will be responsible for developing regulatory strategies, handling submissions, and ensuring timely approvals for pharmaceutical products intended for the Saudi Arabian market.

• SFDA Compliance & Submissions: Ensure all regulatory submissions, approvals, and renewals comply with SFDA guidelines for pharmaceutical products.
• Regulatory Strategy: Develop and implement regulatory strategies to facilitate product registrations, variations, and lifecycle management in the Saudi market.
• Dossier Preparation & Review: Prepare, review, and submit high-quality regulatory dossiers in eCTD format for new drug applications, generics, and renewals.
• Liaison with Authorities: Act as the primary point of contact with SFDA and other regulatory bodies, addressing queries and facilitating approvals.
• Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, Manufacturing, and Commercial teams to ensure regulatory compliance throughout product development and commercialization.
• Regulatory Intelligence: Monitor and interpret changes in Saudi regulatory requirements, updating internal stakeholders and ensuring timely compliance.
• Labeling & Packaging Compliance: Ensure that all product labeling, packaging, and promotional materials meet SFDA guidelines.
• Audit & Inspection Support: Prepare and assist in regulatory audits and inspections by SFDA and other relevant authorities.
• Product Lifecycle Management: Handle post-approval changes, renewals, and regulatory variations efficiently.

Biosimilar Expertise: Strong experience in regulatory submissions and lifecycle management of biosimilar products, with a good understanding of SFDA requirements.

Pay: ₹300,000.00 - ₹600,000.00 per year

Work Location: In person