12 Oct
|
Keuro Life
|
Chennai
12 Oct
Keuro Life
Chennai
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 current-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/
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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
📌 Executive Regulatory Affairs (Chennai)
🏢 Keuro Life
📍 Chennai