Miluše Bernadič (Heryšerová)
Managing Partner at Pharma-Service International s.r.o.- Claim this Profile
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English Professional working proficiency
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German Elementary proficiency
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Bio
Eva Beranova
I’ve had the opportunity to work together with Miluse in multiple pharmaceutical companies and I must say it has been always a pleasure to work with her. Besides her profound knowledge and broad experience in human regulatory which she has a very deep understanding of, she was always extremely helpful and willing to provide a great deal of support and guidance anytime it was needed. She was always available for consultation and eager to solve any obstacle that came in the way. I can tell she is a goal-oriented person who never gives up and is ready to take on any challenges. No matter how complicated the task is, she will always lead the project to a successful end making you feel comfortable that you made a right decision to entrust yourself or your business into her hands.
Šárka Holečková
I had the pleasure of working with Miluše for a year in Zentiva at the Dossier Management Department and, following that, for another two years in the Regulatory Affairs department in Arriello Group. During these years, I found at first a wonderful mentor in her and later a great and reliable colleague. In her work Miluše is diligent, responsible and always seeking the best possible solution. As a natural leader, Miluše always tries to see the bigger picture. She is one of the most organized people I have ever met and her enthusiasm for regulatory affairs is remarkable. Miluše never misses an opportunity to learn something new and, subsequently, uses it to make her work even more efficient. Working with Miluše was very enriching for me on both professional and personal level and, as I know I can a hundred per cent rely on her, I look forward for the time when our career paths meet again in the future.
Eva Beranova
I’ve had the opportunity to work together with Miluse in multiple pharmaceutical companies and I must say it has been always a pleasure to work with her. Besides her profound knowledge and broad experience in human regulatory which she has a very deep understanding of, she was always extremely helpful and willing to provide a great deal of support and guidance anytime it was needed. She was always available for consultation and eager to solve any obstacle that came in the way. I can tell she is a goal-oriented person who never gives up and is ready to take on any challenges. No matter how complicated the task is, she will always lead the project to a successful end making you feel comfortable that you made a right decision to entrust yourself or your business into her hands.
Šárka Holečková
I had the pleasure of working with Miluše for a year in Zentiva at the Dossier Management Department and, following that, for another two years in the Regulatory Affairs department in Arriello Group. During these years, I found at first a wonderful mentor in her and later a great and reliable colleague. In her work Miluše is diligent, responsible and always seeking the best possible solution. As a natural leader, Miluše always tries to see the bigger picture. She is one of the most organized people I have ever met and her enthusiasm for regulatory affairs is remarkable. Miluše never misses an opportunity to learn something new and, subsequently, uses it to make her work even more efficient. Working with Miluše was very enriching for me on both professional and personal level and, as I know I can a hundred per cent rely on her, I look forward for the time when our career paths meet again in the future.
Eva Beranova
I’ve had the opportunity to work together with Miluse in multiple pharmaceutical companies and I must say it has been always a pleasure to work with her. Besides her profound knowledge and broad experience in human regulatory which she has a very deep understanding of, she was always extremely helpful and willing to provide a great deal of support and guidance anytime it was needed. She was always available for consultation and eager to solve any obstacle that came in the way. I can tell she is a goal-oriented person who never gives up and is ready to take on any challenges. No matter how complicated the task is, she will always lead the project to a successful end making you feel comfortable that you made a right decision to entrust yourself or your business into her hands.
Šárka Holečková
I had the pleasure of working with Miluše for a year in Zentiva at the Dossier Management Department and, following that, for another two years in the Regulatory Affairs department in Arriello Group. During these years, I found at first a wonderful mentor in her and later a great and reliable colleague. In her work Miluše is diligent, responsible and always seeking the best possible solution. As a natural leader, Miluše always tries to see the bigger picture. She is one of the most organized people I have ever met and her enthusiasm for regulatory affairs is remarkable. Miluše never misses an opportunity to learn something new and, subsequently, uses it to make her work even more efficient. Working with Miluše was very enriching for me on both professional and personal level and, as I know I can a hundred per cent rely on her, I look forward for the time when our career paths meet again in the future.
Eva Beranova
I’ve had the opportunity to work together with Miluse in multiple pharmaceutical companies and I must say it has been always a pleasure to work with her. Besides her profound knowledge and broad experience in human regulatory which she has a very deep understanding of, she was always extremely helpful and willing to provide a great deal of support and guidance anytime it was needed. She was always available for consultation and eager to solve any obstacle that came in the way. I can tell she is a goal-oriented person who never gives up and is ready to take on any challenges. No matter how complicated the task is, she will always lead the project to a successful end making you feel comfortable that you made a right decision to entrust yourself or your business into her hands.
Šárka Holečková
I had the pleasure of working with Miluše for a year in Zentiva at the Dossier Management Department and, following that, for another two years in the Regulatory Affairs department in Arriello Group. During these years, I found at first a wonderful mentor in her and later a great and reliable colleague. In her work Miluše is diligent, responsible and always seeking the best possible solution. As a natural leader, Miluše always tries to see the bigger picture. She is one of the most organized people I have ever met and her enthusiasm for regulatory affairs is remarkable. Miluše never misses an opportunity to learn something new and, subsequently, uses it to make her work even more efficient. Working with Miluše was very enriching for me on both professional and personal level and, as I know I can a hundred per cent rely on her, I look forward for the time when our career paths meet again in the future.
Experience
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Pharma-Service International s.r.o.
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Czechia
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Managing Partner
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Jan 2022 - Present
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Regulatory Affairs Associate
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Consultant
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Feb 2020 - Present
Global Regulatory Affairs for Medicinal Products: • Management and leading of regulatory affairs projects with the aim to fulfil tight timelines • Preparation and leading of Marketing Authorisation Application for NP/DCP/MRP procedures • Medicinal product Lifecycle - variations, renewals applications • Communication with Authorities • Preparation of eCTD • Preparation of SOPs (in accordance with GxP) Local Regulatory Affairs in the Czech Republic for Medical Products/Medical Devices/ Food Supplements: • Assessment and preparation of PIL/SPC/LAB in local language • Assessment of promotional materials • Notification of Food Supplement • Notification of Medical Device • Act as a local contact person for communication with DRAs • Act as a Qualified person for distribution • Preparation of SOPs (in accordance with GxP) Show less
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Xantis Pharma AG
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Czechia
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Manager
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Jun 2019 - Feb 2020
• Coordination, compilation and submission of new MAA for medicinal products (mostly DCP, MRP procedures) • Lifecycle management of generic products • Notification of food supplements & medical devices in accordance with CZ requirements • Managing of local RA activities for medicinal products in front of Czech authorities (Translation of package information, national variations, notifications...etc) • publishing of eCTD • Coordination, compilation and submission of new MAA for medicinal products (mostly DCP, MRP procedures) • Lifecycle management of generic products • Notification of food supplements & medical devices in accordance with CZ requirements • Managing of local RA activities for medicinal products in front of Czech authorities (Translation of package information, national variations, notifications...etc) • publishing of eCTD
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Arriello
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Ireland
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Regulatory Affair Manager
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Jun 2017 - Jun 2019
• Compilation of the registration dossier and its subsequent processing in the CTD, eCTD, or in other formats applicable in RoW • Active management of the individual registration projects during the entire life cycle of the pharmaceutical products (new registration, renewal, variations, withdrawals) ensuring the registration procedures according to the timetable • Active participation in the process of change management, assessment of impacts and risks resulting from changes in legislation • Communication with Health Authorities • Coordinates cooperation and communication with the assigned clients and vendors • Management of junior members of the RA team, coordination of project activities Show less
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Zentiva
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Czechia
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Pharmaceutical Manufacturing
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700 & Above Employee
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Registration Specialist
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Sep 2016 - May 2017
• Compilation of dossier in compliance with current EU/local legislation with an aim to receive an approval of New registration/variation/Renewal of my own portfolio of Generic products.• Compilation of registration dossier for medicinal products developed in-house• Participation in internal audits• Mentoring of new-comers
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Junior Registration Specialist
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Jun 2015 - Sep 2016
• Collection and coordination of information and preparation of regulatory documentation for submission of new registration/variation/renewal to regulatory agencies or to commercial partners. • Maintenance of regulatory files/database and chronologies in good order.• Responsible for a lifecycle management of my own portfolio of generic products• Preparation of dossier for EU & CIS & Emerging markets (TW, ZA, CH, RU, UA, TH)
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S&D Pharma CZ
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Prague, Czech Republic
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Regulatory Affairs and Pharmacovigilance Associate
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Nov 2013 - May 2015
As Regulatory Affair Associate: • Support/back-up of Regulatory Affairs Manager on a local level • Lifecycle management of medicinal products registered in CZ • Translation of SmPC, PIL & LAB • Responsible for notification of Medical Devices and Food Supplements • Final assessment of Artworks/promotional materials for Medicinal Products, Medical Devices and Food Supplements • Preparation and maintenance of SOPs in compliance with GxP • Communication with SÚKL As Pharmacovigilance Associate: • Preparation and maintenance of SOPs & PSMF • General Pharmacovigilance training of new employees • Reporting of ICSRs • Product Reports to xEVMPD Show less
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Education
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2008 - 2013
Vysoká škola chemicko-technologická v Praze
Ing., Manufacture of Medicinal Products -
Gymnázium Žatec
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