Senior Global Labeling Consultant role. Provide expert guidance on CCDS updates, safety signals, artwork & regional labeling variations. 8+ yrs pharma exp req, with 2+ yrs in labeling/regulatory & knowledge of Australia/NZ market. #GlobalLabeling #RegulatoryAffairs #PharmaConsulting #RemoteJobs #CCDS #SafetySignals
Provide Expert Strategic Guidance on Global Labeling & Regulatory Compliance
This senior consulting role is designed for a seasoned professional who will act as a trusted advisor on complex global labeling initiatives. You will leverage deep expertise in the Company Core Data Sheet (CCDS), safety signal management, and regional regulatory processes to guide clients through labeling updates, impact assessments, and compliance strategies. Your work ensures the accuracy, consistency, and regulatory soundness of product information worldwide.
Your Mission: Lead Strategic Labeling Projects & Client Advisory
You will provide end-to-end consulting services, from strategic planning to execution, ensuring labeling activities align with global regulatory requirements and business objectives.
Labelling-Specific Expertise & Responsibilities:
- CCDS & Labeling Governance: Utilize strong familiarity with the Company Core Data Sheet (CCDS) and its implementation into local labeling and artworks. Manage CCDS governance processes and coordinate impact assessments for technical changes.
- Safety Signal & Update Management: Apply knowledge of Safety Signal Management and Periodic Safety Update Reports (PSURs) to assess and manage their impact on global labeling.
- Regulatory Process Leadership: Guide clients through the regulatory processes for labeling updates (variation categories) across key regions (EU, US, APAC, EAEU), with specific knowledge of Australia and New Zealand requirements.
- Documentation & Submissions: Understand the preparation of the Addendum to Clinical Overview (Module 2.5) to support labeling variations.
- Promotional Review: Review and approve promotional, medical education, and digital content in accordance with approved labeling, providing regulatory guidance to promotion review committees.
Overarching Project & Consulting Expectations:
- Client Advisory & Solution Development: Act as a trusted advisor, framing issues, presenting options, and providing objective business advice to address client-specific needs using industry best practices.
- Project Execution & Leadership: Complete activities within project scope and objectives, understanding impacts on profitability and quality. Collaborate with and guide junior colleagues to resolve problems.
- Business Development & Thought Leadership: Support business solution development, interact professionally with client senior management, and may participate in seminars or author articles to build firm expertise.
- Operational Excellence: Fulfill all job-related responsibilities including timekeeping, deliverable archiving, and participation in internal initiatives.
Who You Are: The Strategic Labeling Expert
You are a client-focused consultant with a robust blend of technical labeling expertise and strategic business acumen.
Requirements:
- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline; Advanced Degree (MSc, PhD, PharmD) preferred.
- 8+ years of experience in the pharmaceutical or biotechnology industry.
- Must include at least 2+ years of direct Global Labeling/Regulatory Affairs experience, combined with other global responsibility that includes knowledge of the Australian and New Zealand markets.
- Client-focused approach with strong results orientation.
- Excellent teamwork, collaboration, and consulting skills.
- Superior interpersonal, intercultural, written, and verbal communication skills.
- Strong critical thinking and problem-solving abilities.
- Proficiency with document management systems and regulatory platforms.
#LI-REMOTE
Ready to Shape Global Labeling Strategy as a Trusted Expert?
If you are a senior labeling professional with strategic consulting skills and a deep understanding of global and APAC regulations, we encourage you to apply.
This remote role offers the opportunity to influence product strategy on a global scale with leading pharmaceutical companies.
