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Gilead

Executive Director, Global Regulatory Operations

For Current Gilead Employees and Contractors:

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

Job Description

About Gilead Regulatory Affairs:

Gilead Regulatory Affairs is a committed and proud team of highly skilled professionals dedicated to helping deliver therapies in the most efficient and effective way to patients with unmet medical need around the world. We bring our passion for science, discovery, and innovative strategic thinking into everything we do. Our advanced regulatory expertise, track record for developing systems and processes, and our commitment to science allow us to play a strategic role as leaders at Gilead and with global regulatory bodies as we seek to develop new therapies for unmet needs.

We are an inclusive and diverse community, which is supported by strong leaders who are committed to providing individual development and growth opportunities while achieving our mission. Our collaborative and supportive structure help support work-life balance for our teams.

About the role:

This is a unique and exciting opportunity for a newly created executive level role within Regulatory Affairs at Gilead. The successful candidate will lead a hardworking staff of ~60 FTEs and 30 contractors based in North America, and the EU.

The Executive Director, Global Regulatory Operations has overall responsibility for executing the vision and mission for Regulatory Operations and represent the department across the organization and with key stakeholders.

Responsibilities:

  • Successful completion of major global/regional initiatives and leads all aspects of global and regional Publishing, Document Processing, Archiving and Automation functions.
  • Direct the design, development, and implementation strategies for global/regional dossier management and planning.
  • Establish the long-term strategy for the team in accordance with internal digital strategy roadmaps
  • Oversee the development plans of individuals in the Regulatory Operations team (including defining career paths and investing in people/teams)
  • Direct all global and regional aspects of the submission, compilation, publishing, document processing, and archiving activities associated with generating highly complex hard copy and electronic submissions within Regulatory Operations
  • Provide leadership to the newly created automation team, who provide automation solutions across the Regulatory Affairs organization
  • Provide skillful cross-functional leadership for complex global filings, and work purposefully and collaboratively with external functions (eg systems & process, portfolio project management) and acquired companies
  • Oversee the creation and implementation of innovative systems, tools and streamlined processes to create and maintain high quality and efficient regulatory submissions
  • Ensure Regulatory Operations systems (eg, Docubridge) are in compliance with existing regulations and processes are aligned across therapeutic areas
  • Responsible for long term planning of resources including succession planning, budgeting and headcounts
  • Manage complex projects to ensure adherence to appropriate regulatory guidelines

Qualifications:

  • 15+ years of relevant experience including 8+ years of experience in a Leadership Position and 2+ years as a Global Head
  • Minimum Education of BA or BS degree
  • Excellent understanding of global regulations for eCTD publishing
  • Proven track record of leading a large global Regulatory Operations organization
  • Established performance history of successfully leading multiple NDA/BLA, and MAA submissions
  • Extensive knowledge of global submissions and regulatory operations processes
  • Ability to direct and lead all aspects of work projects effectively within an environment that has rapidly changing processes, priorities, and deadlines
  • Must be able to streamline all processes from highly complex to routine improving efficiency and productivity
  • Must have excellent verbal, written, organizational and time management skills and attention to detail
  • Ability to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy customers
  • Extensive experience with solving complex problems
  • Established ability to drive towards improvements

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For jobs in the United States:

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.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.

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PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.


For Current Gilead Employees and Contractors:

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

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