Regulatory Affairs Consultant Safety & Labelling

Regulatory Affairs Consultant Safety & Labelling

PAREXEL

Multiple 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