Associate Director, Regulatory Affairs Labeling Compliance

职位描述

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 Compliance plays a critical role in managing compliance, including tracking and monitoring labeling updates and ensuring alignment with governing laws, regulations, and company policies and procedures, as well as providing regulatory strategy and subject matter expertise to drive compliance excellence across end-to-end Global Labeling processes, with a focus on optimizing tools, systems, and workflows to support proactive compliance management. Regulatory Affairs Labelling Compliance, in collaboration with cross-functional parties, including Regulatory and Development teams, Legal, Commercial and external third parties such as strategic partners, translation vendors and regulatory agencies, ensures the seamless execution of labeling changes and delivers essential support during global audits and inspections.

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. Your responsibilities will include building and maintaining strong relationships with vendors, identifying needs, negotiating contracts, managing budgets and seeking opportunities for cost savings, tracking and monitoring performance, risk mitigation, and supply chain optimization with suppliers.

You will be a member of the Global Labeling Compliance Team with considerable responsibilities to develop, continuously improve and innovate global regulatory and labeling policies, practices, processes, tools, team, and other capabilities.

EXAMPLE RESPONSIBILITIES:

• Oversees the management and direction of outsourcing partners and service providers supporting Global Labeling.

• Responsible for partnership management to include contract negotiations, budgeting, approving POs and invoices within the finance system, 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 and issue resolution.

• 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.

• Leads the definition, development, implementation, and continuous improvement of processes and initiatives with service providers, aligning processes and creating/ updating procedural documents, as applicable.

• 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.

• Provides input into systems used and technology discussions with vendors, for example Translation Management system, & AI for translations.

• 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

• BA/ BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry. Experience leading a broad range of regulatory labeling or related activities and contributing to the regulatory strategy for biopharmaceutical products.

• Proven experience leading global teams and projects in regulatory or related strategies, programs, projects, and other activities.

• Demonstrated 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.

• Proven experience in vendor governance and managing vendor relationships, ensuring cost-effective operations, strong project management skills and the ability to manage complex projects, and develop strategic partnerships to support global labeling initiatives.

Knowledge & Other Requirements

• Knowledge of the biopharma industry, including in-depth understanding of other business functions including artwork and manufacturing.

• In-depth knowledge of labeling, artwork, and translation requirements and guidance, including industry best practices and standards.

• 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.

• 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.

• 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.