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.
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Barbara Rossiter
Finance Officer
Barbara manages all of the financial aspects of our ever growing company. She has been with Acorn Regulatory since 2014 and prior to joining the company she worked with one of the world's largest banks.
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Brian Cleary
Chief Marketing Officer
Brian is Chief Marketing Officer at Acorn Regulatory. He works with our growing team to highlight some of the most important issues in regulatory affairs and pharmacovigilance. Brian also manages HR and recruitment issues for the company.
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Bronwyn Kelly
Senior Regulatory Affairs Advisor - Medical Devices
Bronwyn Kelly is a Senior Regulatory Affairs Advisor in our growing medical devices team. She has a wealth of experience in both device and pharmaceutical regulatory affairs and she has worked with some of the world's biggest companies in both sectors, In her current role she works with device clients on issues such as EU Authorised Representative and PRRC (Person Responsible for Regulatory Compliance) related issues.
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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.
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Dr. Danica Cvetkovic
Medical Manager
Dr. Cvetkovic heads up our Clinical & Medical team at Acorn Regulatory. She has significant experience in the clinical and medical sector. Prior to joining our company she headed the medical department of a major pharmaceutical company in her native Serbia.
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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.
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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.
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Fionnuala Fahey
Administrator
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.
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Geraldine Luciano
Pharmacovigilance Advisor
Geraldine has worked in community pharmacy and has seen firsthand how drugs impact of public health. Geraldine is responsible for managing client activities daily across a myriad of duties including Eudravigilance screening, local/global literature review, ICSR processing & reporting, signal detection activities and the collection of regulatory intelligence.
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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.
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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.
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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.
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Mary Stapleton
Senior Regulatory Affairs Advisor - Pharmacovigilance
Mary joined Acorn Regulatory in March 2019 as a Senior Regulatory Affairs Advisor in Pharmacovigilance. She has over 13 years pharmacovigilance experience and is responsible for several pharmacovigilance processes at Acorn Regulatory. Mary is responsible for the management of pharmacovigilance client accounts, ensuring that high level documents such as PSMFs, PVA and SDEAs are maintained. Mary is also responsible for the scientific writing including Risk Management Plans and aggregate report writing.
Natasha Daly
Pharmacovigilance Manager
Natasha joined Acorn Regulatory in October 2018 as Pharmacovigilance Manager. Natasha has over 11 years’ experience in the pharmaceutical industry. Her experience comes from working in a large global innovator pharmaceutical company and a large global generic company and includes drug development, post-marketing and clinical trials. Natasha`s role as pharmacovigilance manager at Acorn Regulatory is intended to ensure that the procedures in place are adhered to and that Acorn Regulatory provides a quality of service to its clients acceptable to any inspecting authority.
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Orla Keane
Senior Regulatory Affairs Advisor Medical Devices
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance.
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Sarah Jane Devaney
Regulatory Affairs Advisor - Pharmacovigilance
Sarah Jane brings to the team a broad knowledge base and she has an array of experience across many disciplines including veterinary, post-marketing, medical information and clinical practice. Sarah Jane is responsible for managing client activities daily across a myriad of duties including Eudravigilance screening, local/global literature review, ICSR processing & reporting, signal detection activities and the collection of regulatory intelligence.
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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.
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