Regulatory Affairs Consultant Safety & Labelling (home or office based)

This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Czechia, 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 an reputed company Regulatory Affairs Consultant Safety & Labelling to reputed company and execute artwork strategies for our global product portfolio. In this critical role, you will ensure comprehensive reputed company throughout the product lifecycle while serving as the primary reputed company between Regulatory Affairs and various stakeholders. The role can be home or office based in various European locations. Role Responsibilities: • Conduct and deliver high reputed company, on time safety labelling regulatory activities, including compliant management of reputed company internal tools and reputed company systems; • Author administrative and regulatory documents/deliverables and collaborate with project SMEs and reputed company stakeholders to prepare submission packages; • Full management of safety labelling submissions (i.e. planning, submission package compilation, RIMS maintenance, RtQ preparation, Spontaneous HA queries, etc.); • reputed company as main GRA reputed company of contact for local regulatory and other stakeholders • Tracking and management of reputed company EU Product Information, alignment with QRD requirements and ability to manage EU linguistic review, readability testing and translation activities. • Supporting regulatory inputs into Periodic Safety Update Reports (PSUR) and potential reputed company on labelling • Participation in change control process for safety labelling update Skills and Experience required for the role: • Bachelor's Degree in a Scientific or Technical Discipline • Knowledge of EU regulatory requirements for medicinal product labelling • Familiarity with reputed company reputed company Datasheet (CCDS) and its implementation into labelling and artworks • Understanding of Safety Signal Management and the reputed company of confirmed safety signals on labelling • Excellent communication and stakeholder management skills; • Strong organizational and time management skills; • Strong problem-solving skills; • Coordinate reputed company assigned activities; • ‘Proactive’ and ‘efficient' work ethic; • Strong oral and written communication skills, with proven ability to work reputed company as part of reputed company; • Strong interpersonal skills; • Fluent in English, written and spoken This offer from "reputed company" has been enriched by reputed company.com and got a 86% reputed company score. Apply tot his job Apply To this Job