Director Global Regulatory Labeling
Director, Global Regulatory Labeling
A leading biopharmaceutical organization dedicated to advancing innovative medicines for patients worldwide is seeking a Director, Global Regulatory Labeling Strategy to join its Regulatory Affairs team.
This individual will provide strategic leadership for global labeling activities across a portfolio of development and commercial products. The role will be responsible for driving labeling strategy, overseeing key labeling deliverables, and partnering with cross-functional stakeholders to ensure labeling content is scientifically accurate, compliant, and aligned with broader product objectives.
The ideal candidate will bring deep regulatory labeling expertise, strong leadership capabilities, and a proven ability to influence stakeholders within a complex global environment.
Key Responsibilities
- Develop and execute global labeling strategies across multiple products and stages of development.
- Lead cross-functional teams in the development, review, and maintenance of product labeling.
- Serve as a strategic labeling advisor to regulatory, clinical, safety, medical, commercial, and quality stakeholders.
- Author, review, and manage labeling content and supporting documentation for global regulatory submissions.
- Drive implementation of labeling updates based on emerging clinical, safety, and regulatory information.
- Support interactions with health authorities related to labeling strategy and content.
- Monitor evolving regulations, guidance documents, and industry trends to inform labeling recommendations.
- Assess competitive labeling landscapes and provide strategic input to support product differentiation where appropriate.
- Ensure labeling activities are executed in accordance with applicable regulations, internal procedures, and project timelines.
- Identify potential regulatory risks and develop appropriate mitigation strategies.
- Support regulatory inspections and audits involving labeling processes and documentation.
- Partner with regional teams to facilitate implementation of global labeling decisions in local markets.
- Contribute to process improvement initiatives that enhance efficiency, quality, and compliance.
- Lead, mentor, and develop regulatory labeling professionals.
- Manage external vendors and consultants supporting labeling activities.
Qualifications
- Bachelor's degree in a scientific discipline required; advanced degree preferred.
- 10+ years of experience within the pharmaceutical, biotechnology, or life sciences industry.
- Significant experience in Regulatory Affairs with a strong emphasis on product labeling.
- Demonstrated success developing and implementing labeling strategies for products in development and/or commercial stages.
- Experience leading cross-functional teams and influencing stakeholders within a matrixed organization.
- Strong understanding of global regulatory requirements, including U.S. and European labeling regulations.
- Experience supporting regulatory submissions and health authority interactions.
- Ability to analyze complex scientific and regulatory information and translate it into clear labeling recommendations.
- Excellent project management, organizational, and prioritization skills.
- Strong written, verbal, and presentation communication skills.
- Proven leadership, problem-solving, and decision-making abilities.
- Prior people management experience preferred.