For our leading Biopharmaceutical client in Switzerland I am looking for a Regulatory Affairs professional with expertise in CMC. RESPONSIBILITIES
Author/review CTD module 3.2 sections for biologics across clinical trials, BLA/MAA, and post-approval submissions.
Manage HA interactions, including responses to questions and scientific advice.
Coordinate activities to meet submission deadlines, collaborating with SMEs and project teams.
Conduct regulatory assessments for change controls and deviations.
Maintain site-specific regulatory documentation and support facility registrations.
Drive process improvements using Lean methodology.
PROFILE
Bachelor’s/Master’s in Biology, Chemistry, Biochemistry, Pharmacy (PhD/RAC preferred).
5+ years in CMC writing for biologics, with knowledge of EU/US regulations.
Strong organizational, communication, and analytical abilities; experience in CMO/CDMO or consultancy is a plus.
Fluent in English (German is a plus).
PRACTICALITIES
Location: Basel (hybrid)
Contract: Initial 12-month contract (high chance of extension)
INTERESTED? If you're excited about this opportunity and believe you're a good fit, please apply with your CV today. Interviews and offers will happen in the coming 2 weeks. For further information, please contact Merel van Os at m.vanos@panda-int.com