Director, Regulatory Affairs CMC Europe Ready to lead the CMC regulatory strategy for novel small-molecule therapies in oncology?
We’re partnering with an innovative biotechnology company that is advancing a portfolio of next-generation targeted oncology therapies. As the pipeline progresses towards global registrations, we’re looking for an experienced Director, Regulatory Affairs CMC – Europe to shape global CMC strategy and play a key role in bringing breakthrough medicines to patients.
Your Responsibilities
Lead the global CMC regulatory strategy for innovative small-molecule development programmes.
Drive CMC activities across clinical development, registration and lifecycle management.
Develop and oversee global CMC submission strategies, including Module 3.
Lead interactions with global Health Authorities, including the FDA and EMA.
Partner closely with Technical Development, Quality, Manufacturing and Supply Chain to ensure successful global submissions.
Assess regulatory risks and provide strategic guidance throughout product development.
What We’re Looking For
Significant experience in
Regulatory Affairs CMC
within the pharmaceutical or biotechnology industry.
Strong background in
small molecules ,
ideally New Chemical Entities (NCEs) .
Experience developing and executing
global CMC regulatory strategies
from clinical development through registration and lifecycle management.
Strong knowledge of
Module 3 , global CMC submissions and Health Authority interactions.
Oncology experience is highly desirable.
A collaborative leader who thrives in a fast-paced, science-driven biotech environment.
Why Join? This is an opportunity to join a highly innovative biotechnology company at an exciting stage of growth. You’ll have a direct impact on the global regulatory strategy of a promising oncology pipeline while working alongside internationally recognised experts in drug development.
Interested? We’d love to tell you more.
#J-18808-Ljbffr
We’re partnering with an innovative biotechnology company that is advancing a portfolio of next-generation targeted oncology therapies. As the pipeline progresses towards global registrations, we’re looking for an experienced Director, Regulatory Affairs CMC – Europe to shape global CMC strategy and play a key role in bringing breakthrough medicines to patients.
Your Responsibilities
Lead the global CMC regulatory strategy for innovative small-molecule development programmes.
Drive CMC activities across clinical development, registration and lifecycle management.
Develop and oversee global CMC submission strategies, including Module 3.
Lead interactions with global Health Authorities, including the FDA and EMA.
Partner closely with Technical Development, Quality, Manufacturing and Supply Chain to ensure successful global submissions.
Assess regulatory risks and provide strategic guidance throughout product development.
What We’re Looking For
Significant experience in
Regulatory Affairs CMC
within the pharmaceutical or biotechnology industry.
Strong background in
small molecules ,
ideally New Chemical Entities (NCEs) .
Experience developing and executing
global CMC regulatory strategies
from clinical development through registration and lifecycle management.
Strong knowledge of
Module 3 , global CMC submissions and Health Authority interactions.
Oncology experience is highly desirable.
A collaborative leader who thrives in a fast-paced, science-driven biotech environment.
Why Join? This is an opportunity to join a highly innovative biotechnology company at an exciting stage of growth. You’ll have a direct impact on the global regulatory strategy of a promising oncology pipeline while working alongside internationally recognised experts in drug development.
Interested? We’d love to tell you more.
#J-18808-Ljbffr
Director CMC RA Arbeitgeber: HeadCount
Headcount ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Zürich eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf persönliche und berufliche Weiterentwicklung sowie einer offenen Unternehmenskultur fördert das Unternehmen die Zusammenarbeit und Innovation. Die Möglichkeit, in einem internationalen Umfeld zu arbeiten und mit verschiedenen Kulturen zu interagieren, macht diese Position besonders attraktiv für talentierte Fachkräfte im Bereich Talent Acquisition.
