pFor our client, we are seeking an experienced bRegulatory Specialist (CMC) /b to support commercial products and post-approval regulatory activities. The focus of this role is lifecycle management, regulatory compliance, change controls, deviations, remediation projects, and maintenance of regulatory records within global systems. /p pThis position is ideal for candidates with strong experience supporting marketed pharmaceutical products in highly regulated international environments. /p h3General Information /h3 pbContract Duration: /b 12 months /p pbExtension: /b Likely /p pbStart Date: /b ASAP /p pbLatest Start Date: /b February 1, 2027 /p pbDepartment: /b Pharma Technical Regulatory (PTR) /p h3Responsibilities /h3 ul liManage global CMC regulatory submissions and post-approval activities for commercial products. /li liEvaluate technical changes and determine regulatory impact. /li liManage change controls, regulatory deviations, and maintenance submissions. /li liMaintain and update regulatory documentation within Veeva systems. /li liSupport remediation projects, legacy data reviews, and regulatory record clean-up initiatives. /li liEnsure ongoing compliance with global and regional regulatory requirements. /li liServe as the primary regulatory representative within cross-functional project teams. /li liIdentify regulatory risks and develop practical mitigation strategies. /li liCollaborate with manufacturing, quality, supply chain, and regulatory stakeholders globally. /li liDrive process optimization and operational excellence initiatives. /li liMonitor evolving regulatory requirements and assess business impact. /li /ul h3Required Qualifications /h3 ul liBachelor's degree or higher in Life Sciences, Pharmacy, Biotechnology, Chemistry, or a related scientific discipline. /li liMinimum 3–4 years of experience in CMC Regulatory Affairs or Technical Regulatory Affairs. /li liStrong experience supporting commercial pharmaceutical products. /li liProven experience with post-approval maintenance and lifecycle management. /li liExperience with change controls, regulatory deviations, and variations.Strong knowledge of Veeva RIM and regulatory information management systems. /li liExperience working with regulatory remediation and data clean-up initiatives. /li liAbility to work independently and manage multiple priorities simultaneously. /li /ul h3Preferred Qualifications /h3 ul liExperience with biologics. /li liPrevious Roche experience or experience within a large global pharmaceutical company. /li liKnowledge of international regulatory frameworks and submission processes. /li liGerman language skills are considered an advantage. /li /ul h3What We Are Looking For /h3 pWe are looking for hands-on Regulatory Affairs professionals who can contribute immediately within a global pharmaceutical environment. Successful candidates combine strong CMC expertise, practical Veeva experience, a proactive mindset, and the ability to navigate complex regulatory challenges while collaborating effectively with global stakeholders. /p #J-18808-Ljbffr
Regulatory Specialist (CMC) – Commercial Products, Lifecycle Management & Remediation Arbeitgeber: Manpower Switzerland
MANPOWER ist ein hervorragender Arbeitgeber, der seinen Mitarbeitenden in Olten nicht nur ein dynamisches Arbeitsumfeld bietet, sondern auch die Möglichkeit zur persönlichen und beruflichen Weiterentwicklung. Mit einem starken Fokus auf Teamarbeit und einer positiven Unternehmenskultur fördern wir die Zusammenarbeit und den Austausch von Ideen, während wir gleichzeitig attraktive Arbeitszeiten und umfassende Schulungsangebote bereitstellen. Unsere Mitarbeiter profitieren von einem abwechslungsreichen Aufgabenspektrum im Bereich Lackierung und haben die Chance, an spannenden Projekten mitzuarbeiten, die einen direkten Einfluss auf die Qualität unserer Fahrzeuge haben.
