Amanda Mitchell

• Phone: +353 87 123 4567
• Email: amanda.mitchell@email.com
• Location: Dublin, Ireland
• LinkedIn: amanda-mitchell-ra

Summary

Over 8 years of experience in regulatory affairs within the pharmaceutical and biotechnology sectors, specializing in EU and global submissions and compliance for novel therapeutics.

Successfully managed the end-to-end regulatory lifecycle for multiple drug products, achieving timely market authorizations and maintaining post-market compliance.

Proven ability to interpret complex regulatory guidelines and translate them into actionable strategies, ensuring adherence to HPRA, EMA, and other international health authority requirements.

Experience

Senior Regulatory Affairs Manager, BioPharma Ireland -- Dublin, Ireland

Mar 2020 – present

• Led a team of 3 regulatory associates in preparing and submitting Marketing Authorisation Applications (MAAs) for two new biological products to the EMA, resulting in approval within 18 months.

• Developed and implemented regulatory strategies for orphan drug designations and accelerated assessment pathways, reducing time-to-market by an average of 6 months.

• Managed post-approval variations, renewals, and pharmacovigilance reporting for a portfolio of 10+ marketed products, maintaining 100% compliance with EU regulations.

• Acted as the primary liaison with the Health Products Regulatory Authority (HPRA) and European Medicines Agency (EMA) during inspections and product reviews.

Regulatory Affairs Specialist, MediTech Solutions Ltd. -- Cork, Ireland

Sept 2016 – Feb 2020

• Prepared and compiled Module 1-5 documentation for CTAs and MAAs in eCTD format, ensuring accuracy and completeness for submission.

• Conducted regulatory intelligence research to monitor changes in EU pharmaceutical legislation and advised cross-functional teams on potential impacts.

• Coordinated responses to health authority queries and deficiencies, contributing to the successful approval of 3 Class IIb medical devices.

• Provided regulatory input for clinical trial protocols, manufacturing changes, and labeling updates, ensuring compliance with GCP and GMP standards.

Junior Regulatory Affairs Associate, PharmaConsult Ireland -- Galway, Ireland

July 2014 – Aug 2016

• Assisted in the preparation of regulatory submissions, including formatting documents and managing submission timelines.

• Maintained regulatory databases and tracking systems for product registrations and licenses.

• Reviewed promotional materials and labeling for compliance with local and international regulations.

• Supported senior regulatory staff in interactions with health authorities and notified bodies.

Education

University College Dublin, MSc in MSc in Regulatory Affairs -- Dublin, Ireland

Sept 2013 – June 2014

National University of Ireland Galway, BSc in BSc in Pharmacology -- Galway, Ireland

Sept 2010 – June 2013

Skills

Regulatory Expertise: EMA Regulations, HPRA Guidelines, ICH Guidelines, eCTD Submissions, MAA/CTA Preparation, Post-Market Surveillance, Pharmacovigilance, QMS, GMP, GCP, GVP

Regulatory Systems & Tools: Veeva Vault RIM, Documentum, TrackWise, MS Office Suite (Advanced Excel, Word, PowerPoint), SharePoint

Compliance & Strategy: Regulatory Intelligence, Risk Assessment, Gap Analysis, Regulatory Strategy Development, Cross-functional Collaboration, Health Authority Liaison

Product Lifecycle Management: New Product Development, Variations & Renewals, Labeling & Artwork Review, Change Control Management, Product Launches