Senior Regulatory Affairs Consultant - Labelling Strategy (Home Or Office Based)
Pubblicato il 16-09-2026 - Parexel in Milano
Overview
In this role you will lead labeling strategy within Global Regulatory Affairs to align CCDS, dCCDS, USPI and EU SmPC across products.
You will influence product development plans, ensure compliant labeling and support commercial opportunities.
You'll collaborate with GRA, GCD, GCSP and cross-functional teams to maintain global consistency and governance.
This is a senior, strategic position with global impact, available in multiple European locations or remote.
Responsabilità
Lead development and maintenance of dCCDS, CCDS, USPI and EU SmPC for assigned portfolio.
Provide labeling strategy input to early development and ensure alignment with regulatory and development plans.
Contribute to study design documents, Investigator Brochures and Briefing Books from a labeling perspective.
Coordinate with SMEs across GCSP, GCD, GRA and CDO to finalize CCDS content and labeling.
Oversee CCDS-USPI/SmPC exception assessments via Global Labeling Committee processes.
Represent Global Labeling in internal/external meetings and maintain cross-functional communication.
Stay up-to-date with global labeling requirements and regulatory expectations.
Build and maintain cross-functional networks across GRA and R&D;/Commercial teams.
Requisiti fondamentali
University degree in Life Sciences or related Pharmaceutical field
Minimum of 10 years' biotech/pharmaceutical industry experience, incl.
6+ years in labeling/regulatory roles
Knowledge of regulatory principles relevant to drug development and post-marketing labeling
Strong ability to interpret scientific documents and translate into labeling content
Proven problem-solving, risk assessment and decision-making capabilities
Proficient understanding of drug/biologic development from pre-clinical to post-clinical labeling implications
Effective communication skills for diverse audiences, including complex concepts
Attention to detail with strategic thinking
Fluency in English (verbal and written)
Strong communication and stakeholder management
Strategic thinking and impact orientation
Cross-functional collaboration
Global labeling knowledge (dCCDS, CCDS, USPI, SmPC)
Regulatory affairs expertise in drug development
Ability to translate science into labeling content