Job description:Develop and implement regulatory strategies for assigned biosimilar productsCoordinate and prepare regulatory submissions and documentation together with affiliate RA teamsSupport regional labelling updates and maintain risk minimization measures (aRMMs)Oversee registration and launch timelines, ensuring timely approvals and implementationCommunicate effectively with internal stakeholders and external partners, including vendors and regulatory authoritiesMaintain up-to-date awareness of relevant regional regulatory legislation and standardsEnsure compliance with internal policies, procedures, and regional requirementsProvide guidance and training to affiliate Regulatory Affairs colleagues where applicableAbout the customer:In this role, you will lead regional regulatory activities for biosimilar products beyond centralized authorization. You will work closely with affiliate Regulatory Affairs teams to ensure national regulatory requirements are met, enabling timely product launches and lifecycle updates across multiple countries. Your contribution will ensure regulatory compliance while supporting efficient and aligned execution of regulatory processes.Competences:Bachelor's degree in pharmacy, chemistry, biology, pharmacology, or another related life sciences discipline3-5 years of experience in the pharmaceutical or biotechnology industry or scientific researchMinimum of 1 year experience in Regulatory AffairsExperience working across multiple regions or markets is considered an advantageStrong organisational and communication skills, with the ability to manage multiple workstreamsCollaborative mindset, able to work closely with internal and external stakeholders j4id9921167a j4it1044a j4iy25a