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
Managing Director
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.
Yvonne McCormack
Pharmacovigilance Manager
Yvonne is the Pharmacovigilance Manager at Acorn Regulatory. In addition to PV qualifications, Yvonne is a qualified QP and brings that same high level of quality to the PV system at Acorn. In her current role she manages a diverse PV team (which includes QPPV, Medical Assessor and UK National Contact Person) conducting Routine Pharmacovigilance, Contract Management, PSMF management, Signal Detection, Aggregate Reporting, RMP preparation and PV Auditing. A recent project has seen the Acorn Regulatory Pharmacovigilance Team open a UK based office to offer UK Pharmacovigilance services to our clients with UK MA’s, including UK PSMF, preparation, maintenance and submission, and National Contact Person services.
Christine McGrath
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 Shortiss
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.
Eileen Ryan
Publishing Manager
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.
Sinead Smyth
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.
Janet Fitzgerald
Project Manager
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.
Fionnuala Fahey
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.
Mandy Cashman
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.
Darren McGrath
Quality Systems Specialist
Darren is a Quality Systems Specialist with Acorn Regulatory. His background is in Industrial Chemistry. Darren’s main focus is acting as a Deputy Responsible Person for our WDA (Wholesale Distribution Authorisation) clients and assisting them with GDP (Good Distribution Practice) related issues. Darren also works with our GMP (Good Manufacturing Practices) clients in relation to MIA (Manufacturer’s Importation Authorisation) activities for Medicinal Products. Since joining the company, he has worked with our clients on issues such as WDA and MIA applications and their associated competent authority inspections, developing GDP and GMP compliant Quality Management Systems and more.
Marie Carroll
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.
Avril Keane
Regulatory Affairs Advisor - Pharmacovigilance
Avril is a qualified Pharmacist with experience in clinical, community and regulatory settings. Avril’s role encompasses all aspects of the PV function at Acorn Regulatory with specialty in scientific report writing. Avril works closely with the Medical Assessor and QPPV in her preparation and critical assessment of ICSR’s for expedited reporting, signal detection reports and PSUR’s. Avril also prepares RMP’s for Clients to support their submissions to the Regulatory Authorities. Avril has built a strong collaborative relationship with our global Clients and their 3rd Parties though her interactions with them on routine PV and reconciliations.