Executive Director, Regulatory Affairs Labeling

Description

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 to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. 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 works closely with cross-functional partners to ensure timely and appropriate delivery of product information and labeling updates, including other Development teams, Legal, Commercial, and external regulatory agencies.

You will lead and oversee the Global Regulatory Affairs (GRA) Labeling organization, inclusive of labeling strategy and labeling operations / compliance. You will provide strategic input and operational leadership and management oversight of regulatory labeling across Gilead's product portfolio. You will oversee or otherwise lead labeling discussions in cross-functional governance and decision-making meetings. You will act as a key advisor to cross-functional partners, stakeholders, and teams. You will oversee or otherwise lead impact assessments on major global labeling issues. You will oversee or otherwise lead the establishment and maintenance of processes for ensuring global labeling compliance based on internal and external standards.

You will be a member of the Innovation, Content, and Operations (ICO) Regulatory Affairs Leadership Team with considerable responsibilities to develop, continuously improve and innovate global regulatory and labeling policies, practices, processes, tools, team, and other capabilities.

EXAMPLE RESPONSIBILITIES:

Leads the GRA Labeling function to ensure compliance with evolving global regulatory requirements and in support of company objectives.

Leads a team of labeling strategists who are responsible for managing core labeling (CCDSs) and US labeling (USPIs) and for oversight of regional labeling globally, for products across all Gilead therapeutic areas.

Accountable for driving an effective and integrated cross functional governance that crosses organizational boundaries.

Leads a team of labeling operations and compliance specialists.

Oversee the development and management of implementation of global labeling and review processes, metrics, and systems. Provides oversight of country labeling deviations from the CCDS.

Accountable for effective and efficient global processes for core and regional labeling development and review that incorporates input from cross-functional subject matter experts and leadership.

Accountable for Gilead labeling activities, including representing the function during internal and external audits and inspections.

Represents the GRA Labeling function globally and interacts with cross-functional senior leadership to resolve complex issues, including leading and contributing to cross-functional initiatives and providing expertise in global labeling best practices.

Hires, develops, and retains diverse top talent. Sets clear and elevating goals for the team and individual direct reports. Coaches and mentors team on their performance, development, and career interests.

Ensures the GRA Labeling team prepares timely, high-quality labeling documents in accordance with applicable regulations and the company position, and in close collaboration with cross-functional global and regional stakeholders, to support regulatory filings and labeling discussions with Health Authorities.

Leads or otherwise oversees Global Safety and Labeling Committee (GSLC) labeling governance discussions. Influences strategic or corporate direction through GSLC labeling agenda topics and background documents, by facilitating GSLC labeling discussions, and by building consensus with cross-functional leaders. 

Owns and manages the resource plans, performance, and budget for the GRA Labeling function.

Drives digital innovation across the global labeling value chain.

Serves as the global process owner for global labeling.

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

PharmD/PhD/MA/MS/MBA/BA/BS with significant relevant experience.

Strong experience in prescription drug labeling. Extensive experience leading development of regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional leaders and teams for multiple medicinal products.

Extensive experience and significant successes setting and directing the regulatory labeling or related strategy to successful conclusion for multiple products.

Extensive experience in NDA/BLA labeling and labeling negotiations.

Strong track record of successes working and negotiating with regulatory authorities.

Significant experience in global prescription drug labeling, including core labeling and regional labeling across U.S., EU, GB, Australia, Canada, Japan, Switzerland, and other markets.

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

Has multiple years’ line management (direct reports) experience. Typically has experience managing other people leaders (with indirect reports).

Leadership experience with high complexity, cross-functional initiatives, including team and governance management, strategy setting, and effective oversight of strategy execution.

Significant experience driving inspection readiness and quality processes across the end-to-end labeling process.

Extensive experience leading labeling transformations across organizational boundaries at global scale.

Proven track record of achieving or exceeding large-scale, complex short- and long-range strategies in life sciences.

Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.

Extensive experience interacting with and presenting to executives and managing large-scale project budgets and other resources.

Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred. 

Knowledge & Other Requirements

Expert-level of knowledge of the biopharma industry, including in-depth understanding of other business functions, as evidenced by proven track record of leading organizations and teams to achieve short- and long-range strategies, plans, and objectives.

Expert-level knowledge in global labeling regulatory requirements and strategy, including industry best practices and standards.

Expert-level 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.

Recognized as a regulatory expert.

Demonstrates ability to rapidly become acquainted with Gilead’s therapeutic areas.

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.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

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