Karen Roels
Manager Regulatory Affairs at Huvepharma nv- Claim this Profile
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Dutch Native or bilingual proficiency
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English Professional working proficiency
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Spanish Limited working proficiency
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French Elementary proficiency
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Bio
Dirk Mariën
During the 10+ years I've worked with Karen I've seen her gaining a lot of experience in various fields within preclinical development and drug safety evaluation and applying her expertise not only in support of small molecule development but also vaccines and chemical hazard assessment within the REACH regulatory framework. She both acted as a study director for in-house in vivo rodent and nonrodent toxicity studies and as a study monitor for outsourced activities. Being well-organized, to the point, honest and reliable, she is an invaluable asset for any organization.
Ann De Smedt
During the past two years I closely worked together with Karen in support of the REACH and cleaning limit project. Due to the huge amount of studies that needed to be performed (some of them with very short timelines) a good organisation and sense of urgency was needed, still keeping in mind the high quality of the results. Being the coordinator of the project, it was a big help for me, to have Karen in the team, since I could totally trust that action was taken when her name was mentioned for a specific task. In addition, Karen made several suggestions to make the cross-departmental process more efficient. Her open communication makes it very nice to have Karen in the team.
Dirk Mariën
During the 10+ years I've worked with Karen I've seen her gaining a lot of experience in various fields within preclinical development and drug safety evaluation and applying her expertise not only in support of small molecule development but also vaccines and chemical hazard assessment within the REACH regulatory framework. She both acted as a study director for in-house in vivo rodent and nonrodent toxicity studies and as a study monitor for outsourced activities. Being well-organized, to the point, honest and reliable, she is an invaluable asset for any organization.
Ann De Smedt
During the past two years I closely worked together with Karen in support of the REACH and cleaning limit project. Due to the huge amount of studies that needed to be performed (some of them with very short timelines) a good organisation and sense of urgency was needed, still keeping in mind the high quality of the results. Being the coordinator of the project, it was a big help for me, to have Karen in the team, since I could totally trust that action was taken when her name was mentioned for a specific task. In addition, Karen made several suggestions to make the cross-departmental process more efficient. Her open communication makes it very nice to have Karen in the team.
Dirk Mariën
During the 10+ years I've worked with Karen I've seen her gaining a lot of experience in various fields within preclinical development and drug safety evaluation and applying her expertise not only in support of small molecule development but also vaccines and chemical hazard assessment within the REACH regulatory framework. She both acted as a study director for in-house in vivo rodent and nonrodent toxicity studies and as a study monitor for outsourced activities. Being well-organized, to the point, honest and reliable, she is an invaluable asset for any organization.
Ann De Smedt
During the past two years I closely worked together with Karen in support of the REACH and cleaning limit project. Due to the huge amount of studies that needed to be performed (some of them with very short timelines) a good organisation and sense of urgency was needed, still keeping in mind the high quality of the results. Being the coordinator of the project, it was a big help for me, to have Karen in the team, since I could totally trust that action was taken when her name was mentioned for a specific task. In addition, Karen made several suggestions to make the cross-departmental process more efficient. Her open communication makes it very nice to have Karen in the team.
Dirk Mariën
During the 10+ years I've worked with Karen I've seen her gaining a lot of experience in various fields within preclinical development and drug safety evaluation and applying her expertise not only in support of small molecule development but also vaccines and chemical hazard assessment within the REACH regulatory framework. She both acted as a study director for in-house in vivo rodent and nonrodent toxicity studies and as a study monitor for outsourced activities. Being well-organized, to the point, honest and reliable, she is an invaluable asset for any organization.
Ann De Smedt
During the past two years I closely worked together with Karen in support of the REACH and cleaning limit project. Due to the huge amount of studies that needed to be performed (some of them with very short timelines) a good organisation and sense of urgency was needed, still keeping in mind the high quality of the results. Being the coordinator of the project, it was a big help for me, to have Karen in the team, since I could totally trust that action was taken when her name was mentioned for a specific task. In addition, Karen made several suggestions to make the cross-departmental process more efficient. Her open communication makes it very nice to have Karen in the team.
Experience
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Huvepharma nv
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Belgium
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Manager Regulatory Affairs
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Sep 2021 - Present
- Co-develop vet med and feed additive projects. - Lead development projects of vet meds and feed additives according to the defined budget and timelines.- Lead regulatory procedures according to defined timelines.- Responsible for pharmacovigilance related activities - deputy QPPV.
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Clinical Trial Manager
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Oct 2018 - Present
- Lead development projects of vet meds and feed additives according to the defined budget and timelines.- Lead regulatory procedures according to defined timelines.- Responsible for pharmacovigilance related activities.
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Marketing & Regulatory Assistant
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May 2018 - Oct 2018
Assistance in marketing and regulatory affairs activities.
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The Janssen Pharmaceutical Companies of Johnson & Johnson
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Early Development Program Management Leader ID&V
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Jan 2017 - Jul 2017
- As active team member of several teams, guide the teams towards the requested milestones. - Follow up timelines and budget, give presentations, make contributions to reports.
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Preclinical Study Director and Study Monitor - Senior Scientist
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Aug 2008 - Jan 2017
- Ensure protocols are set up and experiments are conducted according to GLP guidelines.- Full responsibility and single point of contact for the study and its final report.- Interpretation of all study results and integration of expertise areas were needed.- Study monitor: advisory and supervision role on outsourced studies.- Toxicology representative: point of contact for Project Lead scientists, coordination and follow up of projects on study level.
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The Janssen Pharmaceutical Companies of Johnson & Johnson
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Preclinical Study Director and Study Monitor - Scientist
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2005 - 2008
Study Director and Monitor responsibilities. Study Director and Monitor responsibilities.
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Ghent University
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Belgium
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Higher Education
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700 & Above Employee
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Set up PhD
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Sep 2004 - Dec 2005
“Prevalention and pathogenesis of Mycobacterium avium subspecies avium and Mycobacterium genavense infections in birds.” “Prevalention and pathogenesis of Mycobacterium avium subspecies avium and Mycobacterium genavense infections in birds.”
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Education
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1997 - 2004
Ghent University
Master, Veterinarian -
1997 - 2004
Universiteit Gent
Laboratory Animal Medicine (master), Veterinary Medicine
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