Company Background
Jillian Stewart Regulatory Solutions was established in 2018, to meet the needs of the health products industry in the context of an increasingly demanding regulatory environment. The company was also launched with a view to supporting companies who wish to transition and adapt their business/regulatory models post-Brexit, as well as to provide a convenient service for companies located in the Northwest/Northeast of Ireland. The company specialises in supporting the Irish and Maltese markets, but can also support client requirements across a range of jurisdictions and product categories in the health products industry.
Experience & Qualifications
Jillian has over 14 years’ experience in regulatory affairs within the pharmaceutical industry, where she has developed a broad range of knowledge and skills. Jillian has worked in both the veterinary and medical pharmaceutical arena and comes with a wealth of experience in handling European procedures (particularly post-approval change management), as well as extensive experience in handling all regulatory aspects of mergers, acquisitions and divestments.
With over 10 years’ experience leading a regulatory team in Ireland for Teva Pharmaceuticals (the world’s largest generic pharmaceutical company, and biggest volume supplier of prescription medicines to the Irish market), Jillian has established a strong working relationship with the National Competent Authorities in Ireland and Malta. She has also built a network of contacts across the regulatory system in Europe, spanning medicinal products, medical devices, cosmetics and food supplements.
In addition to her expertise in regulatory affairs, Jillian also has experience in:
- Establishing quality management systems for marketing authorisation holders (MAHs) and wholesale distribution authorisation (WDA) holders
- Coordinating and leading regulatory (MAH) inspections
- Responsible Person (RP)/Deputy RP roles for WDA holders.
Prior to launching her career in regulatory affairs, Jillian completed a B.Sc. in molecular biology at Queen’s University Belfast, followed by a Ph.D. in genetics at Cambridge University. Jillian enhanced her ‘hands-on’ regulatory knowledge by completing the TOPRA M.Sc. in regulatory affairs in 2015, and continues to be actively involved in TOPRA in Ireland, as well as taking a seat on the editorial board of TOPRA’s publication Regulatory Rapporteur.
Jillian has over 14 years’ experience in regulatory affairs within the pharmaceutical industry, where she has developed a broad range of knowledge and skills. Jillian has worked in both the veterinary and medical pharmaceutical arena and comes with a wealth of experience in handling European procedures (particularly post-approval change management), as well as extensive experience in handling all regulatory aspects of mergers, acquisitions and divestments.
With over 10 years’ experience leading a regulatory team in Ireland for Teva Pharmaceuticals (the world’s largest generic pharmaceutical company, and biggest volume supplier of prescription medicines to the Irish market), Jillian has established a strong working relationship with the National Competent Authorities in Ireland and Malta. She has also built a network of contacts across the regulatory system in Europe, spanning medicinal products, medical devices, cosmetics and food supplements.
In addition to her expertise in regulatory affairs, Jillian also has experience in:
- Establishing quality management systems for marketing authorisation holders (MAHs) and wholesale distribution authorisation (WDA) holders
- Coordinating and leading regulatory (MAH) inspections
- Responsible Person (RP)/Deputy RP roles for WDA holders.
Prior to launching her career in regulatory affairs, Jillian completed a B.Sc. in molecular biology at Queen’s University Belfast, followed by a Ph.D. in genetics at Cambridge University. Jillian enhanced her ‘hands-on’ regulatory knowledge by completing the TOPRA M.Sc. in regulatory affairs in 2015, and continues to be actively involved in TOPRA in Ireland, as well as taking a seat on the editorial board of TOPRA’s publication Regulatory Rapporteur.