CMC EU Regulatory Manager -Pharma in Bucuresti

CMC EU Regulatory Manager - Pharma vacancy for a globally operating Glattpark based company in the Pharma sector.Your tasks:Designing and implementing comprehensive EU regulatory strategies to support product approvals and patient accessWorking closely with regional Market Access and Integrated Franchise Teams to ensure regulatory strategies are integrated into wider business goalsManaging regional regulatory submissions, coordinating with health authorities, and ensuring timely approvals through product life cycleOffering strategic advice to internal teams, ensuring that development programs comply fully with EU regulations and operate efficientlyOverseeing CMC regulatory responsibilities, including managing post-approval changes and product updates to maintain EU complianceYour experience/knowledge:In-depth understanding of EU regulations and guidelines for drug and biologics development, including post-marketing requirementsStrong grasp of regulatory affairs concepts and their impact across departments and global functionsProven experience in managing relationships with Contract Research Organizations and other external partners is highly desirableUniversity degree or equivalent experience in a relevant fieldLanguage skills: English - fluentYour soft skills:Excellent comprehension skills with attention to detailA high degree of self-organisation and time managementAnalytical and solution-orientated thinkingLocation:Glattpark, SwitzerlandWork setting:HybridSector:PharmaStart:11/Duration:06+ MMWorkload:%Ref.Nr.:BH Take the next step and send us your resume along with a daytime phone number where we can reach you. Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland. Ukrainian refugees are warmly welcomed, we will support you all the way. We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.