Caolan McGuinness

Regulatory Affairs Senior Specialist at Farmaprojects Polpharma Group

Based in Barcelona, Spain

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Seniority

Staff

Department

Science

Location

Barcelona

Industry

Pharmaceutical Manufacturing

Company size

110

Contact information

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Email

1 credit

c•••••••@farmaprojects.com

Phone

5 credits

+34 ••• •••• ••••

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Background

About Caolan McGuinness

Regulatory Affairs professional with 5 years of experience in authoring variations, compiling, and managing global regulatory submissions across diverse markets, including EU, LATAM, APAC, EMEA and GCC, while working with NeeS and eCTD submissions. Compiling and submission of EU National, EU MRP/DCP and rest of world packages. Experience with Health Authority Questions. Demonstrated expertise in CMC documentation authoring, compliance with international regulatory guidelines, and submission management of packages Modules 1-5. Comfortable working autonomously or collaborating in cross-functional teams. Proactive with great attention to detail. Proficiency in Microsoft Office and wide array of Regulatory Software & Applications. Including but not limited to D2, SAP, docuBridge, TrackWise and Documentum.

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