1. Oversee and coordinate the registration, renewal, maintenance, and variation processes for all Grin Laboratories products, including pharmaceuticals, medical devices, food supplements, and cosmetics, in all countries where the company holds or seeks sanitary registrations.
2. Prepare, compile, review, and submit administrative, legal, technical (quality), and clinical documentation required for the registration, renewal, modification, maintenance, and classification of products before COFEPRIS and other regulatory authorities.
3. Manage and respond to regulatory requirements, deficiencies, warnings, and inquiries issued by health authorities, ensuring timely submission of all necessary documentation to obtain, maintain, or modify sanitary registrations.
4. Monitor and follow up on regulatory projects, documentation, procedures, and activities in all countries where Grin Laboratories markets or intends to market its products.
5. Establish and maintain a regulatory tracking system to monitor the status of registrations, renewals, variations, and ongoing submissions, coordinating with the responsible internal and external stakeholders.
6. Develop and implement departmental dashboards and regulatory intelligence tools, including regulatory impact assessments, to proactively identify opportunities, communicate risks, and support business decision-making.
7. Implement and maintain a document management system that supports business opportunities and compliance requirements, including public tenders, private tenders, wholesalers, distributors, and other commercial channels.
8. Review and approve printed materials and artwork, including cartons, labels, package inserts, instructions for use, and promotional materials, ensuring consistency with approvals granted by COFEPRIS and other regulatory authorities.
9. Maintain accurate and up-to-date product information databases, including registration status, approved product information, product characteristics, and regulatory documentation used for bidding processes, promotional activities, pharmacovigilance, technovigilance, and other business functions.
10. Support continuous improvement initiatives within the Regulatory Affairs department by optimizing processes and implementing best practices related to promotional material review, artwork harmonization, stability programs, regulatory compliance, and quality management systems.
11. Maintain the Regulatory Affairs filing and archiving system, ensuring that all regulatory and product-related documentation is complete, accurate, current, and properly organized in both physical and electronic formats.
12. Collaborate cross-functionally with Quality, Medical, Pharmacovigilance, Commercial, Supply Chain, and other departments to ensure regulatory compliance and support business objectives across all markets.
Bachelor's degree in a Health Sciences field (Pharmaceutical Chemist, Pharmaceutical Chemist, Pharmaceutical Biologist, or related field). Master's degree desirable. Diplomas in regulatory affairs, clinical trials, and drug development phases desirable.
English level: B2
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
