Senior Manager, Regulatory Operations

Gilead Sciences, Inc. Foster City , CA 94404

Posted 3 weeks ago

For Current Gilead Employees and Contractors:

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

Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical 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.

Meet the team:

https://regulatoryaffairs-careers.gilead.com/

  • Our North American publishing team is seeking a leader to join our highly engaged and close working team.

  • As a leader within the Regulatory Operations team, this position manages processes and staff to ensure high quality and timely submission, compilation, and publishing activities associated with generating complex hard copy and electronic submissions within the North America Publishing group.

Job Responsibilities:

Publishing:

  • Manages staff for their areas of expertise and accomplishes results mainly through senior associates and associates.

  • Responsible for medium-term forward planning of publishing resources (up to 1 year out). Has an awareness of long-term filing plans (more than 1 year) and advises senior management of resource implications.

  • Coordinates complex logistical details associated with generating paper/electronic regulatory submissions, including identification and sourcing of submission content, project and timeline planning, oversight of publication activities, and set up and operation of document management, authoring, and publishing tools.

  • Coordinates with regulatory product managers on all targeted submissions.

  • Interfaces with Regulatory Operations globally to ensure technologies, processes and required resources are in line with global Gilead business objectives. Follows and interprets FDA, EMEA and ICH guidelines for electronic submissions.

  • Applies quality control processes to ensure submission integrity.

  • Guides the successful completion of major initiatives.

  • Contributes to the design, development, and implementation strategies for dossier management and planning.

  • Manages multiple projects. Reviews documentation for, and maintains oversight of, the status of multiple projects managed by junior colleagues. Maintains constructive and positive interactions with colleagues.

  • Follows up on and discusses the status of ongoing projects with the team, sets expectations and provides support where necessary and reports on project statuses to senior management. Takes decisions regarding issue resolution.

  • Represents the organization as a technical contact for specific projects.

Knowledge, Experience &

Skills:
  • 8+ years of relevant experience and a BA or BS.

  • 6+ years of relevant experience and an MS.

  • Experience in document management and Regulatory publishing is required.

  • An in-depth familiarity with pharmaceutical development and global Regulatory submissions is required.

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.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

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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Senior Manager, Regulatory Operations

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