Global Regulatory Affairs professional with expertise in CMC, Quality and Compliance. Supporting successful product registrations and lifecycle management across Europe, APAC, LATAM, and the United States.
Global Regulatory Affairs & CMC Expertise
Expertise in CMC and Lifecycle Management
Reliable Expertise for Successful Regulatory Approvals
I offer extensive expertise in Regulatory Affairs and CMC, with a focus on strategic planning and the implementation of variations to support sustainable product success.
18+
Years of experience in a strict regulated pharmaceutical environment.
100+
Successful variation approvals
25+
Product registrations
Strategic Submission Planning
Developing and executing regulatory strategies that support efficient submission, approvals and product lifecycle success.
CMC Expertise
Strong expertise i Chemistry, Manufacturing & Controls, ensuring product quality, compliances, and regulatory readiness.
Lifecycle Management
Managing regulatory activities throughout the product lifecycle, from initial approval to global variations and renewals.
Compliance & Regulatory Excellence
Ensuring compliance with international regulatory requirements while supporting sustainable business growth and patient access.
Kontakt aufnehmen
Telefon: +49 (0) 163 336 1420
E-Mail: franka.juergens@cmcexperten.com
Adresse: Mannheim, Germany