- Leads the GRA Labeling function to ensure compliance with global regulatory requirements.
- Manages a team of labeling strategists overseeing core and regional labeling globally.
- Drives effective cross-functional governance.
- Oversees labeling operations and compliance specialists.
- Develops global labeling processes and review systems.
- Represents GRA Labeling function in audits and interactions with regulatory authorities.
- Leads global Safety and Labeling Committee discussions.
- Manages resource plans and budgets for the GRA Labeling function.
- Focuses on digital innovation in labeling processes.
- Serves as the global process owner for labeling operations.
- PharmD/PhD with a minimum of 10 years' relevant experience.
- MA/MS/MBA with at least 14 years' relevant experience.
- BA/BS with a minimum of 16 years' relevant experience.
- Extensive experience in prescription drug labeling with strong leadership capabilities.
- Proven success in global regulatory labeling strategies and negotiations.
- Management experience with high complexity projects and teams.
- Expertise in global prescription drug labeling and regulatory requirements.
- Track record of influencing and collaborating with internal and external stakeholders.
- Knowledge of digital tools and systems supporting global labeling.
- Expert-level understanding of biopharma industry and global labeling regulations.
- In-depth knowledge of labeling operations compliance and quality management processes.
- Demonstrated ability to influence and collaborate across the organization and externally.
- Strong communication, negotiation, and conflict resolution skills.
- Experience in managing resources, budgets, and high complexity initiatives.
- Ability to travel when required.
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Executive Director, Regulatory Affairs, Labeling - Parsippany-Troy Hills, United States - Gilead Sciences, Inc.
Description
Description
Regulatory Affairs Labeling plays a crucial role within Gilead's Global Regulatory Affairs team, serving as a key partner collaborating with various teams. The focus is on creating and managing product information and labeling documentation for Gilead's product range to ensure compliance with laws, regulations, and company policies. This documentation includes detailed product usage, benefits, dosage, safety information, and side effects for patients and healthcare providers. The Regulatory Affairs Labeling team works closely with different departments to ensure timely updates and deliveries of labeling information.
In this role, you will be leading the Global Regulatory Affairs (GRA) Labeling team, responsible for setting labeling strategies and ensuring compliance. Working closely with cross-functional teams, you will provide strategic guidance and manage regulatory labeling activities for Gilead's products. Your responsibilities will involve overseeing labeling discussions, providing advice to partners, and conducting impact assessments on global labeling issues.
As a member of the Innovation, Content, and Operations (ICO) Regulatory Affairs Leadership Team, you will have significant responsibilities in developing and enhancing global regulatory and labeling practices.
EXAMPLE RESPONSIBILITIES:
REQUIREMENTS:
We celebrate diversity and seek individuals dedicated to serving patients. The ideal candidate should meet the following criteria:
Education & Experience
Knowledge & Other Requirements
