Executive Director, Regulatory Affairs Labeling, Advertising, & Promotion

Executive Director, Regulatory Affairs Labeling, Advertising, & Promotion
United States - California - Foster CityUnited States - New Jersey - Morris Plains

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description


Position Overview:

Regulatory Affairs (RA) Global Labeling and Advertising & Promotion are core functions within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.

You will oversee the RA Labeling and RA Advertising/Promotion functions. You will provide strategic input and operational leadership and management oversight of regulatory labeling activities for all products across Gilead's product portfolio (Virology, Oncology & Inflammation), including development and execution of all regulatory labeling strategies, management, and operational activities for all Gilead products; and oversee or otherwise lead impact assessments on major global labeling issues. You will provide strategic input and management oversight of commercial regulatory activities across Gilead's product portfolio. You will represent Regulatory Affairs on the US Commercial Leadership Team and be a key advisor to other cross-functional partners, stakeholders, and global teams on Labeling and Advertising/Promotion topics.

You will be a member of the broader Global Regulatory Affairs Leadership Team with responsibilities to develop and continuously improve global regulatory policies, practices, processes, tools, team, and other capabilities.

Key Responsibilities:

• Leads the Regulatory Labeling and Advertising/Promotion functions and teams, including leading other people leaders. Hires, develops, and retains team. Sets clear and elevating goals for the team and direct reports. Coaches team on their performance, development, and career interests
  
• Accountable for the successful oversight and completion of the full spectrum of Regulatory Labeling and RA Advertising/Promotion activities and deliverables across Gilead's portfolio of products, compounds, indications, and other projects
  
• Acts as a standing member of the broader Regulatory Affairs Leadership Team with considerable responsibilities to develop and continuously improve global regulatory policies, practices, processes, tools, team, and other capabilities.
  
• Advises executives on the regulatory labeling strategy and pathway to achieve therapeutic area strategic milestones and objectives.
  
• Oversees development and execution of the labeling strategy, including the preparation and maintenance of regulatory labeling activities, for all products and indications across our therapeutic areas
  
• Ensures updates to the CCDS are implemented in the USPIs as well as all local labeling globally, as appropriate
  
• Leads or otherwise oversees Global Safety and Labeling Committee (GSLC) labeling 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
  
• Represent Regulatory Affairs and provide strategic guidance to the US Commercial Leadership Team
  
• Guide team members on Labeling or Promotional Review Committee processes and cross-functional interactions to drive towards decision-making
  
• Leads and oversees development and execution of all commercial regulatory strategies, management, and operational activities for all Gilead brands
  
• Plays a leadership role in advising cross-functional leaders and executives on commercial regulatory requirements and implications for Gilead's marketed products and external communications, including corporate and investor relations communications. Advises executives on the necessary direction to compliantly achieve strategic project objectives that span across all therapeutic areas.
  
• Serves as a PRC leadership and escalation team representative
  
• Makes significant contributions to our abilities to hire, develop, and retain diverse talent with impact in and outside own team
  
• Oversees or otherwise leads key system and process improvements
  
• Owns and manages budgets and resource plans for assigned areas
  
• Ensures teams' work complies with established practices, policies, and processes and any regulatory or other requirements
  

Minimum Qualifications:

• PharmD/PhD/Master's degree with 14+ years or Bachelors Degree with 16+ years of experience in prescription drug labeling and/or regulatory review of promotions for prescription drugs or other biologic products
  
• 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, including extensive experience in NDA/BLA labeling and labeling negotiations and significant experience in global prescription drug labeling, U.S., EU, Australia, Canada, Japan, Switzerland.
  
• Extensive experience leading large 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.
  
• 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 (Virology, Oncology, & Inflammation) and various 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.
  
• Recognized as a regulatory expert.
  
• In-depth knowledge of labeling and/or advertisement/promotional requirements and guidance, including industry best practices and standards.
  
• Demonstrates ability to rapidly learn new therapeutic areas.
  
• Demonstrates in-depth knowledge of current global and regional trends in regulatory affairs and able to apply this to advance and accelerate regulatory strategies for assigned products or projects.
  
• 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
  

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.






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