Luis Gerardo Alcalá Carmona

Ofrezco reducir el tiempo al momento de armar un expediente para para someter ante COFEPRIS y obtener un nuevo registro sanitario, una prórroga o una modificación. Esto se aplica tanto a insumos para la salud de fabricación nacional como extranjeros. Mejoro los procesos de análisis de información y capacito a grupos de trabajo en el ámbito de los asuntos regulatorios (AS). Ofrezco estrategias de trabajo comprobadas en la industria farmacéutica.

Consultant – Regulatory Affairs Specialist (Mar 2022 – Present)
Regulatory Consultant | Mexico City (Freelance)
• Advise national and international companies on registration of MD with FDA in the USA and medical devices, medicines, and MD-Low Risk, for MA COFEPRIS standards, renewals, and technical administrative variations for medium and small size pharmaceuticals laboratories.
• Plan and implement the appropriate regulatory strategy when registering different products in the market.
• Review translations and procedures like expert's stamp for legal documents used in DM, M, and DM-Low Risk dossiers in English, Italian, French, Chinese. • Organize and prepare documents for international submissions, including drafting reports, and preparing documentation for submissions
• Manage relationships for liaison with appropriate regulatory control agencies.
• Create and maintain appropriate registrations for commerce of medical devices and drugs.
• Serve as the regulatory lead and provide active and ongoing regulatory strategic and tactical guidance
• Responsible for performing Regulatory Affairs Training, analyzing procedures, methodologies, and improvement proposal.
• Conduct market analysis and set goal priorities.
• Detect deviations in the procedures used and implement corrections to align activities, helping to avoid future traceability problems.
Achievements:
• Reduced by 25% in the budgeted time to assemble 5 MD Class III with original manufacturer.
• Reduced by 15% the overall documentation review time of the contracting company's regulatory affairs unit.

Amgen – Regulatory Affairs Specialist (Aug 2021 – Feb 2022)
Biotechnology Research | Mexico City (Temporary Contract)
• Review the packing, leaflets, PI, PIL, and annexes implemented in LATAM (9 countries) for the products portfolio, looking for traceability vs. reference information coming from the USA and EU or the MA.
• Identify in timely manner errors in the artworks, PI, PIL, and MA, to homologate documentation in 12 products.
• Support colleagues in Mexico in the preparation, submission, and review of dossiers to COFEPRIS, requesting legal documents (FSC, GMP, LoA, PoA) to foreign subsidiaries. • Support quality system audits by notified bodies, government agencies, and customers.
• Document regulatory strategies for product submissions.
• Generate databases for CAPAs control, legal documentation, and perform a correct review of the annexes.
• Generate checklists for robust approval of annexes at a global level.
• Lead the marketing automation to support company growth in a more efficient way.
• Perform regulatory review of promotional marketing materials, press releases, labeling. • Review labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
Achievements:
• 20% reduction in administrative costs related to certified copies and translations.

NYCE & SGE – Regulatory Affairs Specialist (Sep 2018 – Dec 2020)
Authorized Third Party & Subsidiary Regulatory Consultant | Mexico City
• Review dossier prior submission to COFEPRIS of MD, M, and MD-Low Risk, including new registrations, renewal, administrative and technical variations, as well as drafting clarifying letters that were included in the dossiers.
• Work with allopathic drugs fractions II, IV, V and VI; MD Class I-III, classification I-VI, Implantable (screws, cells, wires) surgical material, auto analyzers, tests and their controls for diagnosis, anesthesia machines, coronary stent and its catheter, vacuum equipment, body analyzers, hospital equipment.
• Creation of an internal evaluation checklist for modifications, achieving homologation of criteria when evaluating a dossier.
• Coordinate dossier assembly projects with international clients such as Barty Medical or InBody.
• Coordinate annual training for 10-20 Regulatory Affairs Specialists or Analysts.
• Review labels, instructions, and IPPs/PI/Leaflet (Wide and reduced).
• Reduce the response time to users, in cases of urgency, through mastering the regulations governing the product and working as a team with the foreign manufacturer and clients such as Pfizer, Bayer, Zydus, OCD, Omron, Mandala, etc.
Achievements:
• Reduction by 75% in the budgeted time for urgent modifications of core health products by having an assertive communication.
• Completion of reassigned projects with a 70% reduction in time by mastering the English language.
• Reached 0% rejection rate by COFEPRIS.
 

Bachelor’s degree in Pharmaceutical Chemist &
Biological Engineering
UNAM, Universidad Nacional Autónoma de México (2015)
 

Diploma in Health Regulation
UNAM, Universidad Nacional Autónoma de México (2021)