Associate Director, CMC Regulatory Sciences

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

With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development.

Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Specific Responsibilities:

  • Responsible for preparing and reviewing technically complex regulatory CMC submissions. Requires extensive interaction with departments within and outside of Pharmaceutical Development and Manufacturing (PDM) for preparing regulatory documents while meeting aggressive timelines.

    Ensures regulatory submissions are in line with regulatory requirements and company policies and procedures. Ensures filings are completed in a timely manner, and that sound scientific justification is employed in CMC regulatory strategy. Provides strategic regulatory advice as appropriate.

  • Responsible for creating and reviewing change controls and controlled documents to support post-approval changes. Ensures information in the change controls and controlled documents are accurate and scientifically sound. Manages change controls to ensure the initiation and implementation of change in a timely and effective manner.

Knowledge, Experience &

Skills:
  • Requires a BS degree in a relevant discipline and minimum 10 years of relevant experience in Regulatory Affairs. An advanced degree is desirable.

  • Must be a detail-oriented, self-motivated, and organized professional, with excellent verbal and written communication skills and interpersonal skills.

  • Must have experience with authoring and thoroughly reviewing regulatory/quality CMC documentation for accuracy and conformance to regulatory/quality requirements. Knowledge of regulatory/quality CMC related requirements is a must.

  • Must be able to work independently with minimal direction. Previous people management experience is required.

#LI-MT1

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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Associate Director, CMC Regulatory Sciences

Gilead Sciences, Inc.