Ciara Walsh is an experienced professional in regulatory affairs and pharmacovigilance, currently serving as Head of Pharmacovigilance and Deputy QPPV at Acorn Regulatory Consultancy Services Limited since January 2023. Prior to this role, Ciara held significant positions including Head of Regulatory Affairs and Pharmacovigilance at Noden Pharma from September 2018 to April 2022, and Director of Regulatory Affairs at Endo Pharmaceuticals from September 2014 to August 2018. Additional roles include Manager of Regulatory Affairs at Paladin Labs, Regulatory Affairs Specialist at Labopharm, and multiple regulatory compliance positions at Mylan. Ciara holds a Bachelor of Science (BSc) in Industrial Microbiology from University College Dublin, earned between 1994 and 1998.
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Acorn Regulatory Consultancy Services Limited
Acorn Regulatory comprises a group of experienced regulatory affairs consultants specialising in Pharmaceutical & Medical Device Regulatory Affairs and Pharmacovigilance. Our consultants have been assisting companies in all stages of growth, from start-ups to established multinationals needing assistance with global regulatory strategy. Our experience spans a broad range of therapeutic categories and thus allows us to fit in easily into existing team structures and meet your requirements with minimum downtime required for training. We are an effective solution for both your short and long-term regulatory or compliance requirements. Our services include (but not limited to): Pharmaceutical Regulatory Applications (New MAA’s) Expert Report Writing/ Due Diligence Reviews Electronic Submissions Staying Compliant (Variations/ Renewals) Gap Analysis Training in Regulatory Affairs or Electronic submissions Pharmacovigilance Qualified Person for Pharmacovigilance (QPPV) Services Electronic reporting to the Authorities & Eudravigilance Collating and managing Signal Detection Reports Routine literature review including local medical publications Medical Device CE Mark Certification European Authorised Representative Services ISO 13485 Certification Post-Marketing Surveillance and Device Vigilance Medical Device Training Programmes Available We have the expertise, tools and processes to ensure that your needs are always met to the highest standards. Discover how Acorn Regulatory's expertise and approach can help you. Please call us on +353 52 6176706, email info@acornregulatory.com or visit our website at www.acornregulatory.com