Parexel
Senior Regulatory Affairs Consultant - Labelling Strategy (home or office based)
- Harrow
- Remote
- Senior
Acts as principal labelling strategist within Global Regulatory Affairs, driving development and maintenance of dCCDS, CCDS, USPI and EU SmPC documents across an assigned product portfolio. Leads Global Labeling Committee reviews of proposed label exceptions and represents labelling on regulatory strategy teams, working with safety, clinical and commercial stakeholders. Home or office based across European locations.
Company Core Data Sheet (CCDS) · Development Company Core Data Sheet (dCCDS) · US Prescribing Information (USPI) +3