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Gilead Sciences, Inc. Executive Director, Head of Global Regulatory Operations in Morris Plains, New Jersey

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Job Description

Position Overview:

This is a newly created opportunity for an Executive Director to provide strategic and operational leadership to our Regulatory Operations around the world. Reporting to the Senior Vice-President of Regulatory Affairs, the Executive Director will work closely with our regional regulatory operations teams and other external partners to ensure that Gilead continues to efficiently plan, publish and deliver a broad variety of regulatory documentation to regulatory authorities in the US, EU, Japan, China, and around the world. This key leadership position will represent Regulatory Operations on the Global Regulatory Affairs Senior Leadership Team and oversee outsourcing activities within the Regulatory Affairs organization.

Key Responsibilities:

  • Define the future vision and implement strategies in close alignment with internal innovation initiatives to ensure that Global Regulatory Operations is recognized as a leader in the industry

  • Lead all aspects of submission publishing and archiving activities globally associated with generating highly complex electronic submissions within Global Regulatory Operations

  • Provide cross-functional leadership for complex global filings and work collaboratively with external functions

  • Lead company mergers and acquisitions for Global Regulatory operations and successfully integrate them into Gilead processes and systems

  • Collaborate closely with different functions within Global Regulatory Affairs to identify opportunities to further leverage the capabilities of the Global Regulatory Operations team in support of operational workflows within the Global Regulatory Organization

  • Identify opportunities to further advance outsourcing strategies to leverage efficiencies in operations and provide more bandwidth to address the growing business needs for marketed products and development programs across the regions

  • Develop deep strategic relationships with vendors and lead governance meetings

  • Responsible for planning of resources, forecasting and budgeting

  • Ensure Gilead follows all regulatory technical guidance requirements for all submissions globally

  • Oversee the implementation of advanced Regulatory Information and Management Systems, Automation tools and streamlined processes to create and maintain high quality regulatory submissions

  • Oversee automation services group and provide strategic direction to build automation tools and bring significant process improvements for global regulatory affairs

  • Provide expertise and technical guidance on electronic submission requirements to Regulatory affairs

  • Manage complex projects to ensure adherence to appropriate regulatory guideline

Minimum Qualifications:

  • Bachelors degree with 16+ years or Master Degree with 14+ years of relevant experience and proven track record in global regulatory operations, including 8+ years of experience in a people leader position

  • Demonstrated proficiency and understanding of global regulations for eCTD publishing

  • Proven track record of leading a large department, ideally based in more than one country

  • Extensive knowledge of global submissions and regulatory operations processes

  • Proven experience in successfully advancing multiple NDA/BLA, and MAA submissions around the world

  • Must be able to streamline all processes from highly complex to routine improving efficiency and productivity

  • Proven track record of implementing outsourcing solution for Regulatory operations

  • Ability to direct and lead all aspects of work projects effectively within an environment that has rapidly changing processes, priorities, and deadlines

  • 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

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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, and Australia employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. T he health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.

The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation.

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