Senior Regulatory Affairs Consultant - Regulatory Labeling Strategist

Responsibilities

• Define and drive global labeling strategy across foundational markets including US, EU, AU, CH, and DE
• Lead the creation, revision, and management of core labeling documents such as CDS, USPI, EU SmPC, and Global Patient Leaflets
• Chair and manage Labeling Review Committees (LRC) and Global Labeling Committees (GLC) to drive decision-making
• Interpret clinical and scientific data to inform labeling content and identify strategic risks or opportunities
• Oversee operational labeling activities, including artwork coordination, EMA linguistic reviews, and U.S. SPL submissions
• Maintain labeling documentation within eDMS and regulatory tracking platforms to ensure audit readiness
• Partner with regional regulatory leads to address Health Authority inquiries and manage country-specific variations
• Review and approve direct-to-consumer advertising and social media content for regulatory compliance

Requirements

• Bachelor’s degree in Life Sciences or a related field
• 5-7 years of experience in the biotech or pharmaceutical industry
• 2+ years of experience in global labeling or regulatory affairs with strategic leadership responsibilities
• Strong knowledge of US, EU, DE, CH, and AU regulatory labeling lifecycle management
• Proficiency with RIMS (e.g., Veeva RIMS) and eDMS (e.g., Veeva)
• Fluency in English (verbal and written)

Preferred Qualifications

• Advanced degree such as MSc, PhD, or PharmD
• Experience with Health Authority negotiations and direct-to-consumer advertising review
• Familiarity with Change Management systems like Trackwise and Adobe Acrobat

Benefits

• Flexible remote work arrangements
• Opportunities for global career growth and professional development
• Mentorship from highly experienced regulatory professionals
• Exposure to diverse therapeutic areas and global client networks

About the Company

Parexel is a global leader in clinical research, helping biopharmaceutical and medical device companies navigate complex regulatory landscapes to bring life-changing therapies to market. We value collaboration, innovation, and a patient-led approach to everything we do.