Sr. Manager, Regulatory Affairs Labeling Execution

Sr. Manager, 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 fulfill their aspirations. Join Gilead and help create possible, together.

FUNCTION: Regulatory Affairs (RA) Labeling
POSITION OVERVIEW:
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.

This role will provide leadership and oversight for vendor governance, strategic sourcing partnerships and initiatives supporting Global Labeling. You will work across Gilead, Kite and external vendors, to manage strategic sourcing needs across global labeling, translations and artwork. Your responsibilities will include building and maintaining strong relationships with vendors, identifying needs, negotiating contracts, seeking opportunities for cost savings, risk mitigation, and supply chain optimization with suppliers.

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.

EXAMPLE RESPONSIBILITIES:

1. Oversees the management and direction of global outsourcing partners and service providers supporting labeling, translations and artwork activities.
2. Responsible for partnership management to include contract negotiations, discussing new work requirements, expectations and volumes, managing role descriptions for suppliers, monitoring KPIs, metrics, supplier compliance and deviations, supplier CAPA involvement in collaboration with the Quality team, issue resolution, managing a centralized budget for translations, and approving POs and invoices within finance system.
3. Coordinates communication between global outsourcing partners and relevant internal stakeholders, including Global Labeling, Regulatory Affairs and Labeling Operations (Artwork), to ensure timely and appropriate interactions and effective labeling compliance and execution.
4. Leads the definition, development, implementation, and continuous improvement of processes and initiatives with service providers, aligning processes and creating/ updating procedural documents, as applicable.
5. Partners with Vendor Governance and attends relevant meetings to provide updates relating to strategic sourcing. Sets up and attends regular vendor meetings and develops and maintains relationships. Develops training material and provides vendor trainings for outsourced activities.
6. Provides input into systems used and technology discussions with vendors, for example Translation Management system, & AI for translations.
7. Supports outsourcing partner inspection readiness activities when applicable, including support of audits for applicable vendors.

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.

Education & Experience

1. A good level of experience in prescription drug labeling
2. Experience leading global teams and projects in regulatory or related strategies, programs, projects, and other activities.
3. Leadership experience with high complexity, cross-functional initiatives, including team and governance management, strategy setting, and effective oversight of strategy execution.
4. Experience driving inspection readiness and quality processes across the end-to-end labeling process.
5. Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.
6. Experience in vendor governance and managing vendor relationships, ensuring cost-effective operations, strong project management skills and the ability to manage complex projects, and developing strategic partnerships to support global labeling initiatives.

Knowledge & Other Requirements

1. Familiarity with vendor management/ oversight.
2. Working knowledge of the drug development process.
3. Knowledge of the biopharma industry, including in-depth understanding of other business functions including artwork and manufacturing.
4. In-depth knowledge in labeling operations compliance, including quality management processes and systems.
5. In-depth knowledge of systems, tools, metrics, and digital technologies to support global labeling.
6. In-depth knowledge of labeling, artwork, and translation requirements and guidance, including industry best practices and standards.
7. Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications.
8. Proven ability to influence up, down, and across the organization and externally in a collaborative manner.
9. Ability to lead and influence programs, projects and / or initiatives.
10. Exceptional interpersonal skills and understanding of team dynamics.
11. 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.
12. Strong negotiation and conflict resolution skills.
13. Advanced coaching capabilities to mentor/develop staff.
14. When needed, ability to travel.

#J-18808-Ljbffr