Director, Regulatory Affairs Labeling Execution

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling Execution plays a key role in providing regulatory strategy and expertise to drive operational excellence in end-to-end processes for RA labeling, translations and artwork, as well as ensuring that product labeling and associated documents comply with governing laws, regulations, and company policies and procedures. Regulatory Affairs Labeling Execution collaborates closely with cross-functional partners including other Regulatory and Development teams, Legal, Commercial and external third parties such as strategic partners, translation vendors and regulatory agencies, to ensure compliant, timely and appropriate delivery of product information labeling, translations and artwork updates. In this role you will lead labeling operations for global and regional labeling documents, including translations and artwork for products within multiple therapeutic areas from submission through approval and to implementation into packs in the markets. Labeling documents may include Company Core Data Sheets (CCDS), United States Package Inserts (USPI), EU Summary of product characteristics (SmPC), and product labeling for other applicable territories. This role is essential for ensuring that all labeling documents are compliant with internal Standard Operating Procedures (SOPs) and external regulatory requirements, to facilitate effective review by health authorities and other stakeholders, and ensure quality in product information labeling. You will be a member of the Global Labeling Execution Team with considerable responsibilities to develop, continuously improve and innovate global regulatory and labeling policies, practices, processes, tools, team, and other capabilities.

RESPONSIBILITIES:

• Leads and oversees global labeling operations for core and regional labeling, translations and artwork, including proposing operational strategy, and defining, developing and implementing process improvements and initiatives.
• Partners with cross-functional colleagues and vendors to execute core and regional labeling, translation and artwork deliverables, ensuring consistency and quality at every stage of the product lifecycle, in adherence with regulatory requirements and timelines.
• Supports the design, implementation, and continuous improvement of standardized processes, Standard Operating Procedures (SOPs), and work instructions related to core and regional labeling, translations and artwork.
• Agrees and implements outsourcing strategy applicable to core and regional labeling including SPL, translations and artwork.
• Ensures labeling documents meet the relevant regulatory requirements e.g., PLR, QRD.
• Ensures completion of applicable regulatory submissions, such as Member State Linguistic Review and Closing Sequences.
• Works with Global Labeling Leads (GLLs) and RA Liaisons to centralize artwork management, in collaboration with Labeling Operations (Artwork) and manufacturing sites.
• Liaises with owners of systems used for artwork and translations to ensure appropriate use and maintenance of processes and workflows.
• Raises, informs, and resolves any issues that may impact operation activities for core and regional labeling, translations and artwork, including submission process or timelines, working with all applicable parties.
• Manages error process for labeling, translations and artwork, in collaboration with Quality, to ensure compliance and harmonization and to support inspection readiness activities.
• Provides support for global HA audits/ inspections and legal requests relating to translations and artwork.
• Ensures ongoing awareness of regulatory intelligence relating to labeling, translation and artwork activities e.g., changes to Regulatory Agency guidance such as QRD template updates, and timely and appropriate dissemination to stakeholders.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

• Extensive experience leading development of end to end labeling process regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional leaders and teams for multiple medicinal products.
• Significant experience in global management of drug labeling, including core labeling and regional labeling across U.S., EU, GB, Australia, Canada, Japan, Switzerland, and other markets.
• Experience leading global teams and projects in regulatory or related strategies, programs, projects, and other activities.
• Leadership experience with high complexity, cross-functional initiatives, including team and governance management, strategy setting, and effective oversight of strategy execution.
• Experience driving inspection readiness and quality processes across the end-to-end labeling process.
• Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.
• Knowledge of the biopharma industry, including in-depth understanding of other business functions including artwork and manufacturing.
• In-depth knowledge in labeling operations compliance, including quality management processes and systems.
• In-depth knowledge of systems, tools, metrics, and digital technologies to support global labeling.
• Proven ability to influence up, down, and across the organization and externally in a collaborative manner.
• Strong executive presence with demonstrated influence through leadership both on program teams and organizational initiatives.
• Exceptional interpersonal skills and understanding of team dynamics.
• Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution.
• Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans, and strategic objectives.
• Strong negotiation and conflict resolution skills.
• Advanced coaching capabilities to mentor/develop staff.
• When needed, ability to travel.