Guadalupe, Nuevo León, Mexico · On-site
Job Description 1. Oversee and coordinate the registration, renewal, maintenance, and variation processes for all Grin Laboratories products, including pharmaceuticals, medical devices, food supplements, and cosmetics, i…
Skills: Regulatory Affairs, Registration Management, COFEPRIS Compliance, Documentation Management, Pharmacovigilance
Guadalupe, Nuevo León, Mexico · On-site
Descripción del trabajo 1. Supervisar y coordinar la inscripción, renovación y actualización de los registros en todos los países donde Laboratorios Grin cuente con registros sanitarios. 2. Establecer un control de actua…
Skills: Regulatory Affairs, Health Registrations, COFEPRIS Compliance, Quality Management Systems, Pharmacovigilance
Guadalupe, Nuevo León, Mexico · On-site
Vive tu propósito y marca la diferencia con Grupo PiSA. Con más de 80 años de historia, Grupo PiSA es una empresa 100% mexicana comprometida con la salud y el bienestar de millones de personas, tanto en México como a niv…
Skills: Mixture Preparation, Good Manufacturing Practices (GMP), Aseptic Techniques, Quality Systems, Waste Counting
Guadalupe, Nuevo León, Mexico · On-site
En FEMSA generamos valor económico y social y buscamos ser el mejor empleador y vecino. A través de nuestras Divisiones de Proximidad, Salud y Digital y Unidades de Negocio Coca-Cola FEMSA y FEMSA Negocios Estratégicos, …
Skills: Industrial Safety, Occupational Health, Risk Analysis, Regulatory Compliance, Audit Management
Guadalupe, Nuevo León, Mexico · On-site
Position Summary Responsible to act as manufacturing liaison and coordinate all activities affecting the introduction of new products into the manufacturing cycle. Responsible for development and expense control of manuf…
Skills: Process Engineering, Manufacturing Engineering, Infection Prevention, Healthcare Product Support
Guadalupe, Nuevo León, Mexico · On-site
Gracias por tu interés en unirte a Solventum. Solventum es una empresa nueva en el ámbito de salud, pero con una sólida experiencia en la resolución de desafíos que transforman vidas y fortalecen el trabajo de los profes…
Skills: Supply chain management, Demand analysis, Raw materials planning, Forecast management, Purchase order management
Guadalupe, Nuevo León, Mexico · On-site
En FEMSA generamos valor económico y social y buscamos ser el mejor empleador y vecino. A través de nuestras Divisiones de Proximidad, Salud y Digital y Unidades de Negocio Coca-Cola FEMSA y FEMSA Negocios Estratégicos, …
Skills: Occupational Health, Industrial Safety, Medical Care, SASSO, Civil Protection
Guadalupe, Nuevo León, Mexico · On-site
Vive tu propósito y marca la diferencia con Grupo PiSA. Con más de 80 años de historia, Grupo PiSA es una empresa 100% mexicana comprometida con la salud y el bienestar de millones de personas, tanto en México como a niv…
Skills: Sanitary Regulation Compliance, Controlled Medication Management, Good Storage Practices, Regulatory Audits, Health Authority Liaison
Guadalupe, Nuevo León, Mexico · On-site
Gracias por tu interés en unirte a Solventum. Solventum es una empresa nueva en el ámbito de salud, pero con una sólida experiencia en la resolución de desafíos que transforman vidas y fortalecen el trabajo de los profes…
Skills: Power BI, Carrier Management, Team Leadership, Oracle, English Language
Guadalupe, Nuevo León, Mexico · On-site
Job Description Ejecutar las actividades de Acondicionamiento de los productos cumpliendo con las Buenas Prácticas de Acondicionamiento, Buenas Prácticas de Documentación y cumpliendo con los Procedimientos Normalizados …
Skills: Packaging, Manufacturing, Pharmaceutical Industry, Good Manufacturing Practices, Documentation
Guadalupe, Nuevo León, Mexico · On-site
Vive tu propósito y marca la diferencia con Grupo PiSA. Con más de 80 años de historia, Grupo PiSA es una empresa 100% mexicana comprometida con la salud y el bienestar de millones de personas, tanto en México como a niv…
Skills: Project Management, AutoCAD, HVAC Calculation, CAPEX Administration, As-Built Drawings
STERIS Mexico S. de R.L. de C.V. (Operations)Guadalupe, Nuevo León, Mexico · On-site
Position Summary ¿Buscas una oportunidad para desarrollar tus prácticas profesionales? STERIS, empresa líder en el sector de manufactura busca practicantes para el área de Manufactura. Requirements • Estudiante activo de…
STERIS Mexico S. de R.L. de C.V. (Operations)Guadalupe, Nuevo León, Mexico · On-site
Position Summary ¿Buscas una oportunidad para desarrollar tus prácticas profesionales? STERIS, empresa líder en el sector de manufactura busca practicantes para el área de Laboratorio Químico. Education Degree High Schoo…
Skills: Manufacturing
STERIS Mexico S. de R.L. de C.V. (Operations)Guadalupe, Nuevo León, Mexico · On-site
Position Summary The Quality Engineer is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP, FDA 21 CF…
Skills: Statistical Analysis, CAPA Investigations, Quality System Auditing, Sampling Plans, SPC
STERIS Mexico S. de R.L. de C.V. (Operations)Guadalupe, Nuevo León, Mexico · On-site
Position Summary ¿Buscas una oportunidad para desarrollar tus prácticas profesionales? STERIS, empresa líder en el sector de manufactura busca practicantes para el área de Manufactura. Requirements • Estudiante activo de…
Guadalupe, Nuevo León, Mexico · On-site
Vive tu propósito y marca la diferencia con Grupo PiSA. Con más de 80 años de historia, Grupo PiSA es una empresa 100% mexicana comprometida con la salud y el bienestar de millones de personas, tanto en México como a niv…
Skills: Customer Service, Pharmaceutical Mixing, Dimensional Analysis, Pharmaceutical Regulations, Microsoft Office
Guadalupe, Nuevo León, Mexico · On-site
Vive tu propósito y marca la diferencia con Grupo PiSA. Con más de 80 años de historia, Grupo PiSA es una empresa 100% mexicana comprometida con la salud y el bienestar de millones de personas, tanto en México como a niv…
Skills: Process Control, Sterile Mixing Preparation, Quality Management Systems, Good Manufacturing Practices, Good Documentation Practices
Guadalupe, Nuevo León, Mexico · On-site
Vive tu propósito y marca la diferencia con Grupo PiSA. Con más de 80 años de historia, Grupo PiSA es una empresa 100% mexicana comprometida con la salud y el bienestar de millones de personas, tanto en México como a niv…
Skills: Customer Service, Delivery Processes, Courier Services, Invoicing, Travel Expense Management
Guadalupe, Nuevo León, Mexico · On-site
Vive tu propósito y marca la diferencia con Grupo PiSA. Con más de 80 años de historia, Grupo PiSA es una empresa 100% mexicana comprometida con la salud y el bienestar de millones de personas, tanto en México como a niv…
Skills: Equipment Validation, Systems Qualification, Process Validation, Cleaning Validation, Metrology
Guadalupe, Nuevo León, Mexico · On-site
Vive tu propósito y marca la diferencia con Grupo PiSA. Con más de 80 años de historia, Grupo PiSA es una empresa 100% mexicana comprometida con la salud y el bienestar de millones de personas, tanto en México como a niv…
Skills: Equipment Validation, Systems Validation, Process Validation, Cleaning Validation, Quality Systems
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The role involves overseeing the registration, renewal, and maintenance of pharmaceutical and medical products with regulatory authorities like COFEPRIS. It also requires managing regulatory documentation, monitoring compliance projects, and collaborating cross-functionally to support business objectives.
Candidates must hold a bachelor's degree in a health sciences field such as Pharmaceutical Chemistry or Biology. A master's degree and diplomas in regulatory affairs or clinical trials are considered highly desirable.
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
There is only one reason why we exist — to treat diseases, to heal and enrich human life.
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.
Offices: 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santa Cruz East, Mumbai, Maharashtra 400055, IN · B/4 Laxmi Towers, Bandra Kurla Complex, Bandra (E),, Mumbai, Maharashtra 400051, IN · S Calvert St, Harborplace Tower, 21st Floor, Baltimore, Maryland 21202, US · Landis-Gyr-Strasse, Zweigniederlasssung Zug, Zug, Zug 6300, CH · Steenberg Office Park Silverwood Close Westlake,, 1st Floor Grapevine House,, Cape Town, Cape Town 7945, ZA
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