Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Regulatory Affairs Consultant Safety & Labelling (home or office based)
Job ID R0000037590 Bucharest, București, RomaniaWe are seeking an experienced Regulatory Affairs Consultant Safety & Labelling to develop and execute artwork strategies for our global product portfolio. In this critical role, you will ensure comprehensive oversight throughout the product lifecycle while serving as the primary liaison between Regulatory Affairs and various stakeholders.
The role can be home or office based in various European locations.
Role Responsibilities:
Conduct and deliver high quality, on time safety labelling regulatory activities, including compliant management of all internal tools and client systems;
Author administrative and regulatory documents/deliverables and collaborate with project SMEs and client 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.);
Act as main GRA point of contact for local regulatory and other stakeholders
Tracking and management of all 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 impact 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 the Company Core Datasheet (CCDS) and its implementation into labelling and artworks
Understanding of Safety Signal Management and the impact of confirmed safety signals on labelling
Excellent communication and stakeholder management skills;
Strong organizational and time management skills;
Strong problem-solving skills;
Coordinate all assigned activities;
‘Proactive’ and ‘efficient' work ethic;
Strong oral and written communication skills, with proven ability to work efficiently as part of a team;
Strong interpersonal skills;
Fluent in English, written and spoken
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