Dr. Benita von Glahn
Angestellt, Member of Global R&D Executive Leadership and Head of Gloal Regulatory Affairs, Merz Therapeutics
Frankfurt am Main, Deutschland
Über mich
Senior Regulatory Affairs Executive with 25 years global pharmaceutical industry experience operating on international level. Accelerating drug development for patient's and society's benefit is motivating he to perform on highest level of professionalism. She is focussing on regulatory innovation and strategy as this is enabling the acceleration of drug development and thus availability for patients. Evenly important to her are developing people and organizations to create mindsets and the supporting organizational set-up to achieve the ambitious goals. Innovative, creative and highly assertive regulatory leadership personality. She has been successfully leading multinational and cross-functional scientific and academic professional teams in different major global pharmaceutical companies. Throughout her 25 years in pharmaceutical industry she has built a broad global regulatory expertise for medicinal products and medical devices offering an impressive set of skills
Werdegang
Berufserfahrung von Benita von Glahn
Bis heute 10 Monate, seit Juli 2023
Member of Global R&D Executive Leadership and Head of Gloal Regulatory Affairs
Merz TherapeuticsDriving the global R&D strategy with the executive leadership team and global responsibility for all regulatory activities for Merz Therapeutics’s Business
4 Jahre und 5 Monate, Sep. 2018 - 2023
Senior Vice President Global Regulatory Affairs
Boehringer IngelheimGlobal responsibility for all Human Pharma regulatory activities, leading 11 regulatory professionals directly, steering a global organization of 400 professionals Leading, motivating and devolving talent and leadership personalities through establishing a culture of open communication, respectful feedback and a learning organization As a member of the Medicine Leadership team steering the Medicine Excellence activities to focus on speed, value, digital and people as the main drivers for success
Global responsibility for all Biosimilar and Immunology developmental programs, leading 8 regulatory professionals Leading team to achieve submission and approval of first BI biosimilar Providing strategic regulatory input to move several immunology compounds into later development phases Successfully managing regulatory part of a license collaboration leading to approval of a new Psoriasis drug - Skyrizi® Leading restructuring of global regulatory affairs to establish strategy- and country-facing functions
1 Jahr und 11 Monate, Feb. 2013 - Dez. 2014
Senior Director Global Regulatory Affairs Biosimilars
Boehringer IngelheimGlobal Regulatory Strategy of all Biosimilar developments, leading a team of 11 regulatory professionals Building a regulatory team for this new therapeutic area for BI Establishing Regulatory Scientific Advice guidance (timing & content of package) Developing a regulatory strategy template Ensuring key learnings from Regulatory Scientific Agency meetings affecting overall development approaches are applied across all biosimilar programs Creating and aligning processes for a Biosimilar CCDS
Responsibility for Humira/ABT874, leading 14 Professionals, 50 indirect global professionals in USA, EU and APAC Providing critical contribution to implement new department structure, specifically regulatory strategy group and cross-functional operating model Leading global regulatory strategy resulting in EU approval for Humira Axial Spondyloarthritis, first drug ever approved in this disease Ensuring conditions to lead successfully the regulatory approval process for Ulcerative Colitis including US Ad Com
5 Jahre, 2007 - Dez. 2011
Director International Pharmaceutical Regulatory Affairs
Abbott in DeutschlandResponsible for International Immunology team as well as Germany-based International regulatory functions, leading 12 Professionals Creating EU Center for Certificates and Samples as coordination center for all EU CPPs, Samples and GMP/MLs Ensuring Humira approval in Japan as well as for juvenile idiopathic arthritis age 12-17 Submitted a newly required EU Risk Management Plan, which was approved for Humira Submitted first Paediatric Investigational Plan (PIP) for Abbott, receiving approval for Humira
Responsible for regulatory activities. i.e. Scientific Advice, Clinical Trial Applications, initial registrations and variations for assigned Immunology projects Leading scientific advice processes (EU/US) and Clinical Trial Applications for global clinical programs for Humira Crohn’s Disease, Psoriatic Arthritis and Ankylosing Spondylitis Driving global approval process for Humira Psoriatic Arthritis and Ankylosing Spondylitis Ensuring Humira Pen EU approval as a further improved administration device
3 Jahre und 1 Monat, Dez. 1998 - Dez. 2001
Director Drug Regulatory Affairs
Mundipharma
Responsible for all regulatory activities for Antiseptics, Antiasthmatics, Pain Medication and Medical Devices Driving initial registration of Oxygesic 80 mg controlled release tablet for German market to ensure commercialization Managing all German/EU medical devices for Mundipharma to ensure compliance with regulatory and documentation requirements enabling their market access Coordinating all regulatory department needs for implementation of the newly implemented company-wide document management system
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