Principle CMC Expert
Vor 3 Tagen
Overview This role provides senior technical leadership across Drug Product manufacturing and development within a cross-functional biosimilars environment. The position reports to the Head of CMC/SCM and carries end-to-end accountability for technical transfers, Clinical and external manufacturing oversight, and lifecycle support. Key Responsibilities:● Lead end-to-end technical transfers to and between CDMOs, with full accountability for planning, execution, risk, and budget management across global partners. ● Act as senior SME for Drug Product manufacturing and formulation development, supporting development, scale-up, validation, and commercial readiness. ● Drive technical due diligence and strategic assessment of CDMOs, influencing partner selection and long-term manufacturing strategy. ● Provide technical oversight of external manufacturing, including troubleshooting, change controls, deviations, CAPAs, and inspection readiness (e.g. PAI). ● Support Regulatory Affairs with technical input for IND/BLA submissions, health authority interactions, and responses, while ensuring strong cross-functional alignment. Experience & Skills: ● 7+ years in the (bio)pharmaceutical industry with hands-on experience in biologics/biosimilars manufacturing, MSAT, and technical transfers, including CDMO oversight. ● Strong knowledge of cGMP and regulatory expectations, with proven ability to operate independently in a matrix, fast-paced, global environment. ● Excellent communication, documentation, and stakeholder management skills, with a hands-on, accountable, and pragmatic mindset.
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Senior Expert Regulatory Affairs
Vor 5 Tagen
Zug, Schweiz gloor&lang AG VollzeitShape CMC regulatory strategy for complex biologics in a fast-growing biotech environment For a fast-growing, internationally active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Regulatory Affairs with a strong CMC focus. Workplace is Region Zug-Zurich in Switzerland, 3d office required. This is a key role...
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Senior Expert Regulatory Affairs
Vor 5 Tagen
Zug, Schweiz gloor&lang AG VollzeitShape CMC regulatory strategy for complex biologics in a fast-growing biotech environment For a fast-growing, internationally active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Regulatory Affairs with a strong CMC focus. Workplace is Region Zug-Zurich in Switzerland, 3d office required. This is a key role...
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Senior Expert Regulatory Affairs
Vor 3 Tagen
Zug, Schweiz gloor&lang AG VollzeitShape CMC regulatory strategy for complex biologics in a fast-growing biotech environment For a fast-growing, internationally active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Regulatory Affairs with a strong CMC focus. Workplace is Region Zug-Zurich in Switzerland, 3d office required.This is a key role...
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Sr CMC Regulatory Affairs Project Consultant
vor 2 Wochen
Zug, Schweiz Actalent VollzeitSr CMC Regulatory Affairs Project Consultant On behalf of our client, a biotech company focused on rare diseases, we are looking for a CMC Regulatory Affairs Specialist for a 50% contract position. *Please note that we can only consider EU/Schengen applications, or valid Swiss permit Responsibilities Act as the regulatory referent CMC expert, defining...
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Senior Expert Regulatory Affairs
vor 1 Tag
Zug, Schweiz gloor&lang AG VollzeitShape CMC regulatory strategy for complex biologics in a fast-growing biotech environmentFor a fast-growing, internationally active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Regulatory Affairs with a strong CMC focus. Workplace is Region Zug-Zurich in Switzerland, 3d office required.This is a key role...
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Senior Expert Regulatory Affairs
vor 1 Tag
Zug, Schweiz gloor&lang AG VollzeitShape CMC regulatory strategy for complex biologics in a fast-growing biotech environmentFor a fast-growing, internationally active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Regulatory Affairs with a strong CMC focus. Workplace is Region Zug-Zurich in Switzerland, 3d office required.This is a key role...
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Senior Expert Regulatory Affairs
Vor 4 Tagen
Zug, Zug, Schweiz gloor&lang AG VollzeitShape CMC regulatory strategy for complex biologics in a fast-growing biotech environmentFor a fast-growing, internationally active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Regulatory Affairs with a strong CMC focus. Workplace is Region Zug-Zurich in Switzerland, 3d office required.This is a key role...
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Senior Expert Regulatory Affairs
Vor 4 Tagen
Zug, Zug, Schweiz gloor&lang AG VollzeitShape CMC regulatory strategy for complex biologics in a fast-growing biotech environmentFor a fast-growing, internationally active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Regulatory Affairs with a strong CMC focus. Workplace is Region Zug-Zurich in Switzerland, 3d office required.This is a key role...
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Senior Regulatory Affairs
Vor 3 Tagen
Zug, Schweiz gloor&lang AG VollzeitA leading biotech company located in Zug is seeking a Senior Expert in Regulatory Affairs with a strong CMC focus. The candidate will play a key role in defining regulatory strategies, authoring essential documents, and supporting health authority interactions. With at least 7 years of experience and a related MSc or PhD, the candidate will thrive in a...
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Manager/associate Director
vor 13 Stunden
Zug, Schweiz GSK Vollzeit**Site Name**: UK - London - New Oxford Street, Switzerland - Zug, UK - Hertfordshire - Stevenage **Posted Date**: Nov 25 2024 Are you interested in a highly visible regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs CMC role could be an ideal opportunity to...
