Team · Regulatory Affairs
Dr. Sylke Pioch
Regulatory Affairs
Key areas
What Sylke is responsible for at A&O.
Dr. Sylke Pioch works in regulatory affairs and has 20 years of experience in the pharmaceutical industry, more than 15 of them in CMC writing for biotechnological medicinal products. After studying biochemistry, she completed her doctorate with a focus on signal transduction. She knows the regulatory phases of a medicinal product from late development through the authorisation procedure to lifecycle management, and prepares the GMP-relevant documentation for each of them. At A&O Pharma, she works in regulatory affairs and document preparation and supports operational quality management and quality assurance.
- CMC writing for biotechnological medicinal products
- Marketing authorisation
- Strategic consulting
- EU authorisation procedures
- Lifecycle maintenance
- Pharmaceutical quality management
- Product launch
- Mergers and acquisitions, due diligence
Education
Degree in biochemistry, doctorate with a focus on signal transduction, 20 years of experience in the pharmaceutical industry
Case studies
Case studies from Sylke's areas of work.
Anonymised projects from the services Sylke is responsible for.
The whole company
