Senior Regulatory Affairs Consultant
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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.
- 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
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