Director, Regulatory Affairs (Labeling)

The Position:
Director of Regulatory Affairs, Labeling lead responsible for end-to-end global regulatory labeling strategy across all phases of development and post-approval.

Responsibilities:
- Collaborate cross-functionally to develop labeling strategy and lead labeling meetings.
- Manage development, review, approval, and version control of labeling documents (Target Product Labeling, Core Labeling [e.g., CCDS], Regional Labeling [e.g., USPI, EU SmPC]).
- Maintain expertise on key labeling requirements; advise stakeholders on labeling principles.
- Research competitor/therapeutic-class labels to guide labeling text and develop contingency strategies for regulatory negotiations.
- Proofread and perform departmental QC to ensure deliverable quality and consistency with data and regulations.
- Liaise with stakeholders to obtain labeling input, resolve regulatory issues, and implement labeling changes.
- Partner with Clinical Regulatory and cross-functional teams for labeling supplements/updates and health authority interactions.
- Disseminate approved labeling documents and supporting documentation; maintain controlled records and communicate updates.
- Participate in continuous improvement for the end-to-end labeling process.
- Monitor the global regulatory environment and assess impact on labeling activities.
- Facilitate internal policy development and updates.

Requirements:
- Bachelor’s degree in life sciences, computer science, or related science discipline.
- 8+ years in biotech/pharma leading product labeling development/maintenance across two or more major geographic areas.
- Knowledge of advertising promotion regulations and FDA guidance; technical experience in drug development/labeling.
- Experience leading cross-functional meetings and negotiating complex labeling issues.
- Ability to review labeling documents for accuracy and regulatory adherence.
- Strong document formatting knowledge (MS Word, PDF compliance, validation tools).
- Professionalism, integrity, and diplomacy.

Preferred:
- Experience with regulatory information management systems (e.g., Veeva RIM, Registrations).
- AI applications knowledge in regulatory operations.
- Experience supporting global inspection readiness.

Benefits/Pay:
- California pay range: $210,000 USD - $230,000 USD.
- Competitive salaries and an excellent benefit package.

Application instructions:
- Candidates must have current, valid authorization to work in the country where the role is located.