Parexel is seeking an experienced Senior / Regulatory Affairs Consultant - Labeling to provide strategic leadership and operational oversight for complex global labeling initiatives. This role is integral to developing the regulatory labeling content that supports the safe and effective use of products worldwide.
What You'll Do
- Define and drive global labeling strategy across foundational and non-foundational markets (US, EU, AU, CH, DE).
- Lead creation, revision, and management of core labeling documents, including Core Data Sheet (CDS), USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile.
- Align labeling content and strategy across U.S., EU, and global regulatory teams; facilitate timely endorsement of labeling decisions by senior leadership.
- Interpret clinical and scientific data to inform labeling content and product claims; identify strategic risks and opportunities.
- Remain current with global labeling regulations and provide training to internal stakeholders.
- Chair and manage Labeling Review Committee (LRC), Global Labeling Committee (GLC), and CCDS Working Team—set agendas, drive decisions, and ensure timely implementation.
- Develop and maintain governance frameworks for company positions (DLS, CCDS, USPI, EU SmPC) and foundational markets.
- Influence external labeling landscape through policy intelligence and strategic engagement.
- Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S. SPL submissions.
- Maintain labeling documentation within eDMS and regulatory tracking platforms; ensure robust version control and SOP adherence for audit readiness.
- Manage change control documentation, specimen requests, and verify part numbers for correct submissions.
- Ensure FDA Section 508 accessibility compliance on U.S. labels.
- Support regional implementation of CDS updates and monitor compliance across markets.
- Partner with regional and local regulatory leads to address Health Authority inquiries and manage country-specific labeling variations.
- Prepare RFIs, differences tracking tables, and lead negotiations with Health Authorities.
- Review and approve direct-to-consumer and marketing advertising, medical education, and social media content for compliance.
- Manage and proofread artwork for foundational markets, TOLL, PAHO, and ASUs; oversee mock-ups and production for combination products/devices.
- Lead annual strain updates for Northern/Southern Hemisphere flu campaigns.
- Manage labeling for US Drug Listing Reports, including NDC assignments and annual reporting.
What We're Looking For
- Bachelor’s degree in Life Sciences or a related field.
- 5-7 years of experience in the biotech/pharmaceutical industry.
- 2+ years in global labeling/regulatory with strategic leadership responsibilities.
- Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings.
- Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management.
- Experience with direct-to-consumer advertising, social media review, and Health Authority negotiations.
- Must be familiar and able to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise).
- Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS.
- Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing (US, EU, AU, DE preferred).
- Demonstrated problem-solving ability with risk analysis and sound decision-making.
- Strong collaboration skills, with experience working in global, cross-cultural, matrix environments.
- Organizational skills to interact seamlessly both internally and externally on compliance matters.
- Proficient regulatory knowledge, including scientific concepts within labeling and their global implications.
- Effective communication skills for explaining concepts, options, and impacts.
- Attention to detail with the ability to think strategically.
- Fluency in English (verbal and written).
Nice to Have
- Advanced degree (MSc, PhD, PharmD).
- Additional languages would be an asset.
Technical Stack
- RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, Change Management systems (e.g., Trackwise)
- Microsoft Office, SharePoint, Adobe Acrobat, TVT, Promomats, GLAMS
Work Mode
This is a local-country role open to candidates in the US and Canada.
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
