Sr. Director, Global Regulatory Affairs Labeling
United StatesFull-TimeDirector
Salary243,800 - 301,100 USD per year
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Job Details
- Experience
- 12+ years
- Required Skills
- ComplianceStakeholder management
Requirements
- Advanced degree in life sciences (PhD, PharmD, or MSc preferred).
- 12+ years of experience in biotechnology or pharmaceutical industries.
- Deep global labeling expertise.
- Strong background in regulatory affairs, development, and/or post-marketing activities across US and EU markets.
- Proven expertise in global labeling processes, including strategy development and operational execution.
- Excellent scientific writing skills.
- Strong leadership capabilities with experience managing and developing high-performing teams.
- Demonstrated ability to make sound decisions in complex, ambiguous regulatory environments.
- Strong communication, negotiation, and stakeholder management skills.
- Strategic thinker with the ability to balance regulatory requirements with business objectives.
Responsibilities
- Lead the global labeling function and serve as the internal expert on labeling regulations.
- Own the end-to-end labeling strategy for all programs from development through commercialization.
- Oversee the creation, review, and approval of all labeling components, including prescribing information, package inserts, CCDS, and packaging artwork.
- Develop and author labeling text supporting regulatory submissions and lifecycle updates.
- Ensure labeling strategies are fully aligned with broader regulatory and program objectives.
- Chair labeling governance forums and drive senior-level alignment.
- Lead, mentor, and develop global teams responsible for labeling strategy and operations.
- Provide expert guidance on evolving regulatory requirements and global labeling best practices.
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