Meet The Acorn Regulatory Team
Our team members are all highly qualified and experienced professionals. We have recruited from industry and health authorities to assemble a team that can deliver for your company on every project.
Our regulatory team comprises individuals with considerable experience in the pharmaceutical manufacturing sector. They each have in excess of 15 years at the highest level in the industry.
Our clinical and pharmacovigilance team has a diverse range of experiences that clients can utilise. Senior members of the team have experience of managing clinical trials while others have significant experience of managing the pharmacovigilance and clinical departments at CRO’s.
Our medical devices team comprises a group of device specialists who have worked with some of the world’s leading device companies and national competent authorities. They have a vast range of expertise in all types of devices. The Acorn Regulatory quality services team leverages the expertise of specialists who have spent their careers leading quality initiatives for globally known companies and dynamic small and medium enterprises.
Our team of permanent staff (featured below) are supplemented by a team of approximately 40 contractors who work with us on an ongoing basis.
Acorn Regulatory is an ISO 9001 accredited company.
Dr. Gemma Robinson
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts. Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects.
Senior Regulatory Affairs Advisor Pharma
Christine McGrath is an experienced Senior Regulatory Affairs Advisor at Acorn Regulatory. She works with companies around the world on issues relating to pharmaceutical regulatory affairs. At present, she is also working with our Clinical team on a groundbreaking veterinary clinical trial.
Eileen Ryan is the Regulatory Publishing Manager at Acorn Regulatory. In her current role she contributes to the strategic planning/preparation of regulatory submissions in collaboration with other departmental representatives and manages publishing team to ensure the successful publishing of high quality, compliant submissions in the relevant eCTD/NeeS formats to the health authorities.
Senior Regulatory Affairs Advisor - Pharmacovigilance
Eileen Shortiss joined Acorn Regulatory in 2006. During her time with Acorn Regulatory, Eileen has worked on a vast array of projects for clients all over the world. Eileen is extensively involved with pharmacovigilance KPIs and driving continuous improvement measures across the department. Furthermore, she has considerable expertise and experience in the area of patient information leaflets.
Fionnuala manages the day to day running of a very busy Acorn Regulatory office. Prior to joining Acorn Regulatory, she spent many years in senior roles with one of Ireland's largest banks, Bank of Ireland.
Janet Fitzgerald manages some of the larger projects that the company's pharmaceutical and CMC team are working on. She has a wealth of experience in the regulatory affairs sector.
Quality Systems Specialist
Mandy Cashman is a Quality Specialist with Acorn Regulatory and focuses on assisting clients with GDP related issues. Since joining the company she has worked with companies around the world in assisting them on issues such as Wholesale Distribution Authorisations, developing Quality Management Systems and more.
Regulatory Affairs Advisor
Marie Carroll is a Regulatory Affairs Advisor with Acorn Regulatory and focuses on issues relating to Chemistry, Manufacturing and Controls. Prior to joining the company she spent over 15 years in senior roles with a large pharmaceutical company.
Regulatory Affairs Advisor - Publishing
Sinead Smyth is responsible for supporting the Regulatory Affairs Team in the submission publishing process for the preparation of regulatory documentation in eCTD, NeeS or paper formats as required. Her works involves compiling, formatting and publishing regulatory activities to ensure a high quality, compliant, valid and timely submission to the health authorities.