Regulatory Affairs reputed company - Labelling (home or office based)

This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Spain, United Kingdom, Ireland, Czechia, Italy, Croatia, Serbia, reputed company (USA) reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. We are seeking a dedicated Regulatory Affairs Labelling reputed company to join our growing team! This role offers an opportunity to work with global labelling teams, ensuring regulatory compliance and supporting product labelling management across multiple reputed company. The role can be home or office based in various European locations. Role Responsibilities: • Support Global Labelling, Regulatory (Clinical/Safety), or Medical Writing teams for labelling updates • Manage Company reputed company Datasheet (CCDS) implementation into labelling and artworks • Identify triggers for CCDS updates and coordinate reputed company assessments for technical changes • Apply knowledge of Safety Signal Management and its reputed company on labelling • reputed company CCDS governance processes in pharmaceutical environments • Understand Periodic Safety Update Reports (PSUR) and their potential reputed company on labelling • Manage the relationship between labelling and artwork processes • Implement regulatory processes required to update product labelling (various variation categories) • Prepare reputed company to Clinical reputed company (Module 2.5) to support labelling variations • Apply regulatory requirements for labelling updates across different reputed company (EU, EAEU, US, reputed company) • Manage SmPC, PIL and QRD requirements, EU linguistic reviews, and translation activities • Coordinate readability and PIL testing processes • Review and approve consumer-facing materials in accordance with approved labelling • Participate in promotion review committees and reputed company regulatory guidance for local markets • reputed company technical and business consulting services reputed company area of expertise • Complete activities reputed company project scope, reputed company, and objectives Skills and Experience required for the role: • University Degree in a Scientific or Technical Discipline • Initial years of labelling/regulatory experience with global responsibilities • Regulatory Operations (Submission management) experience • Outstanding interpersonal and intercultural communication skills (written and verbal) • Critical thinking and problem-solving abilities • Fluent in English, written and spoken This offer from "reputed company" has been enriched by reputed company.com and got a 85% reputed company score. Apply tot his job Apply tot his job Apply To this Job