cmc regulatory

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...

pJohnson Johnson Innovative Medicine is recruiting a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products, to lead regulatory strategies for complex programs. This hybrid role based in Allschwil, Switzerland requires guiding cross-functional teams and Health Authority interactions across global programs. /ppThe role emphasizes strategic...

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...

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...

pWork 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. /ppSchwerpunkt liegt auf post‑approval Regulatory Maintenance, Change Controls, Regulatory Deviations,...

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...

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...

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...

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...

pManpower Switzerland seeks an experienced Regulatory Specialist (CMC) to support lifecycle management, regulatory compliance, and post-approval activities for commercial pharmaceutical products. The role emphasizes managing change controls, deviations, and remediation within global systems. /ppThe ideal candidate will have a Life Sciences background and...

pWork Selection AG in Basel is seeking a Regulatory Specialist (CMC) for a 12-month temporary assignment. You will handle Health Authority interactions for CMC information, including IND, IMPD, and CTAs, with a focus on early clinical development and IMP support. /ppStrong regulatory expertise, collaboration with global teams, and Veeva DMS proficiency are...

CARBOGEN AMCIS AG in Bubendorf, Schweiz, sucht einen Manager RAC (Regulatory Affairs & CMC) zur Koordination der CMC-Entwicklung für Small Molecules und ADCs. Sie arbeiten eng mit dem Corporate RAC sowie dem Schweizer Regulatory Affairs Team zusammen und unterstützen regulatorische Aktivitäten von Präklinik bis Markteinführung.Zu Ihren Aufgaben gehören...

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...

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...

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

pAt 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...

Johnson & Johnson Innovative Medicine is recruiting a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products, to lead regulatory strategies for complex programs. This hybrid role based in Allschwil, Switzerland requires guiding cross-functional teams and Health Authority interactions across global programs.The role emphasizes strategic...

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 aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the...

pSintetica, 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. /ppReporting to the...