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Angelique Winzenrieth

VP International Regulatory Affairs Management chez PTC Therapeutics, Inc.

Angelique Winzenrieth is a seasoned Regulatory Affairs professional with 25 years of experience in the Biopharmaceutical industry and Clinical Development, including working in CROs.

She has a strong focus on orphan medicinal products addressing high unmet medical needs, spanning across biotechnology products and small molecules.

Angelique is known for her entrepreneurial mindset, exemplary leadership skills, high energy levels, and deep passion for her work.

Some of her key achievements include obtaining EU Marketing Authorisation for critical medications like Lojuxta® for treating Homozygous Familial Hypercholesterolemia and Benefix® for Hemophilia B under Exceptional Circumstances.

With a rich background in Regulatory Affairs, Angelique has effectively managed Centralized and Mutual Recognition Procedures for multiple orphan medicinal products, including biotechs and cell therapies.

Her expertise extends to overseeing EU pre-requisites for Marketing Authorisation Application submissions, conducting various regulatory inspections, and managing regulatory compliance programs for specific therapeutic areas.

Angelique has led workshops and training sessions on diverse topics like Common Technical Document, Registration of Biotechnology Products, and Clinical Development of Vaccines, showcasing her comprehensive knowledge base.

She has a broad experience in therapeutic areas such as Hemophilia, Orthopedics, Ophthalmology, Oncology, Psychiatry, Cardiovascular diseases, Metabolic diseases, and Neuromuscular diseases.

Her managerial experience includes line management and leading project teams composed of around 30 individuals, demonstrating her adeptness at overseeing multifaceted projects.

Angelique Winzenrieth holds a Master's degree in Production Management & Innovation and a PharmD in Pharmacy from Université Louis Pasteur (Strasbourg I).

Angelique Winzenrieth
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Location

Strasbourg Area, France