Daniel Langa García Email & Phone Number

Madrid - Comunidad De Madrid (Spain)

o Global leadership, elaborating and coordinating regulatory operations infrastructures and activities for regulatory publishing/submission activities globally.o Maintenance of regulatory intelligence ensuring compliance with regulatory guidelines. o Implementation of Regulatory Information Management Systems (RIMS), Electronic Document Management System (EDMS) and publishing tools.o Development of business processes, publishing standards and training programmes.

Madrid - Comunidad De Madrid (Spain)

o Coordination and preparation of regulatory submission/publishing activities in different regions/procedures. o Maintenance of regulatory intelligence to ensure legislation compliance, client needs and training.o Regulatory strategy and consulting implementation of market launches and electronic software solutions.

Barcelona - Barcelona (Spain)

o Clinical trials, initial and post-marketing authorizations application dossiers prepared and coordinated.o RIMS (Regulatory Information Management Systems) databases implemented and maintained. o CMC (Chemistry, Manufacturing and Control) and Module 1 documentation oversighted and prepared.

Aranda De Duero - Burgos (Spain)

o New drug products/substances, launches and transfers projects led from development to market. o Logistical, technical, quality and regulatory activities strategically planned and coordinated.o International representative and local expert between sites and stakeholders for the projects assigned.

Aranda De Duero - Burgos (Spain)

o Projects led on API (Active Pharmaceutical Ingredients) and Medical Devices for MDI (Metered Dose Inhalers) and ANS (Aqueous Nasal Sprays) drug products. Deviations, complaints and change controls handled. o Manufacturing, packaging, analytical and qualifications procedures designed and executed. o CMC regulatory strategies, submissions and compliance activities developed and coordinated.

Aranda De Duero - Burgos (Spain)

o PLM (Product Lifecycle Management) designed and implemented according to ICH Q8-Q9-Q10-Q12. o Analytical, statistical and data trending protocols for process/productivity improvements established.o TRA (Technical Risk Assessment) and PCS (Product Control Strategy) established for industrial manufacturing.

Master'S Degree In Research, Development And Drug Innovation (R&D&I), Pharmacy

o Preclinical/Clinical research, Quality, Regulatory affairs and Research management modules learned. o Master´s degree final project.

Education record

https://farmafir.com/ National Healthcare System examination preparation for Hospital Pharmacist.

Double Degree In Pharmacy & Human Nutrition And Dietetics