Regulatory Affairs Consultant, Safety & Labelling
Parexel
full-time
Posted on:
Location Type: Hybrid
Location: Bucharest • 🇷🇴 Romania
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Conduct and deliver high quality, on time safety labelling regulatory activities
- Author administrative and regulatory documents/deliverables
- Full management of safety labelling submissions
- Act as main GRA point of contact for local regulatory and other stakeholders
- Tracking and management of all EU Product Information
Requirements
- 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
- Fluent in English, written and spoken
Benefits
- Health insurance
- Flexible working hours
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory activitiessafety labelling submissionsadministrative documentsregulatory documentssafety signal managementEU regulatory requirementsCompany Core Datasheet (CCDS)labelling implementationartworks management
Soft skills
communication skillsstakeholder managementorganizational skillstime managementproblem-solving skills
Certifications
Bachelor's Degree in a Scientific or Technical Discipline