cmc regulatory

pHeadcount is seeking a Director of Regulatory Affairs CMC Europe to lead the regulatory strategy for novel small-molecule therapies in oncology. This role requires steering global CMC development, submissions and lifecycle management across clinical, regulatory and manufacturing functions, with a focus on Module 3 and interactions with FDA/EMA. /ppThe...

pFlexsis in Basel, Switzerland is seeking a Regulatory Specialist (m/f/d) focusing on CMC regulatory activities for clinical and early-stage development. The role is full-time in Basel with a 12-month contract, likely extendable, and an earliest start date soon with 1 February 2027 latest. /ppYou will support global regulatory submissions for investigational...

pGi Group is seeking a Regulatory Specialist (CMC) in Pharma Technical Regulatory (PTR) based in Basel, Switzerland, to lead global regulatory submissions for clinical and commercial products. The role emphasizes post-approval maintenance, lifecycle management, and proactive regulatory strategy with cross-functional teams. /ppYou will collaborate with...

pMonte Rosa Therapeutics seeks a seasoned Associate Director of CMC Regulatory Affairs to shape global CMC strategy and author critical submission content. You will collaborate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply to ensure compliant, high-quality filings. /ppYou will drive Module 3 content, quality...

pActalent is seeking a Regulatory Specialist (CMC) to drive global regulatory submissions for clinical-stage products and to support IMPDs, CTAs and related CMC documentation. You will liaise with cross-functional teams across development, manufacturing and quality to ensure alignment with Health Authority expectations. /ppThe role requires 3–4+ years in...

Work Selection AG sucht Regulatory Specialist (CMC) für Roche Basel in Basel für eine 12‑monatige befristete Anstellung. Sie arbeiten im PTR‑Team und unterstützen technische regulatorische Aktivitäten über den Produktlebenszyklus hinweg. Schwerpunkt liegt auf post‑approval Regulatory Maintenance, Change Controls, Regulatory Deviations,...

pActalent in the Basel area seeks a Regulatory Specialist (CMC) with 4+ years of experience to support lifecycle management, regulatory maintenance, and post-approval submissions for commercial pharmaceutical products. The role emphasizes change controls, remediation, data management in Veeva and Veeva RIM and collaboration across functions. /ppYou will...

Roche in Basel sucht einen Regulatory Specialist im Bereich klinische Entwicklung (CMC-Fokus). Sie steuern globale regulatorische Einreichungen, arbeiten eng mit PTR, Behörden und Partnern zusammen und begleiten Produkte vom frühen Entwicklungsstadium bis zur Markteinführung.Sie verfügen über einen Bachelor, C1-Englisch, 3–4 Jahre...

Roche in Basel sucht einen Regulatory Specialist – Kommerziell / Post-Marketing Sanierung. Sie steuern globale CMC-Einreichungen, arbeiten eng mit cross-funktionalen Teams zusammen und beraten zu regulatorischen Strategien.Sie bringen 3–4 Jahre Erfahrung in CMC-Regulierungsfragen und exzellente Englischkenntnisse (C1) mit und arbeiten idealerweise mit...

pMonte Rosa Therapeutics, Inc is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategies for Chemistry, Manufacturing, and Controls across development stages. You will author Module 3 content, review summaries, and partner with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams to...

pMonte Rosa Therapeutics, Inc. is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategy for Chemistry, Manufacturing and Controls. /ppYou will author Module 3 submissions, coordinate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams, and represent CMC in health authority...

pJohnson Johnson in Allschwil, Switzerland, seeks a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. This hybrid role focuses on leading regulatory strategies for complex combination product programs and providing expert guidance on global requirements. /ppYou will support cross-functional teams, mentor colleagues, and interact...

At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...

pWork Selection AG is seeking a Regulatory Specialist (CMC) for a 12-month assignment in Basel, supporting Roche's early clinical development programs. The role focuses on handling Health Authority interactions, including IND, IMPD, and related CTAs, with emphasis on IMPs and early development. /ppYou will collaborate with global teams, maintain Veeva-based...

pGi Group is seeking a Regulatory Specialist (CMC) in Pharma Technical Regulatory (PTR) to lead global regulatory submissions and manage CMC information for IND, IMPD, and NDA/BLA/MAA filings. The role collaborates with affiliates, policy teams, and partners on early clinical stage programs and IMPD submissions. /ppThe ideal candidate has 3–4 years of CMC...

ppThe Senior Manager Global Regulatory Affairs CMC - Biological Non-Biol. Products is responsible for: /ppPartnering closely with CSL’s RD, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

Sintetica, founded in 1921 and based in Mendrisio, Switzerland, seeks a CMC Senior Specialist to manage CMC activities for drug product registrations, lifecycle management, and regulatory compliance throughout the product lifecycle. You will prepare and maintain CMC documentation and serve as the focal point for regulatory interactions.Reporting to the CMC...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...