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Gilead

Director, CMC Regulatory Sciences

For Current Gilead Employees and Contractors:

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

Job Description

Specific Responsibilities and Skills for Position:

Work closely with the Analytical Operations and other CMC functional groups, as well as with Regulatory Affairs to plan and produce high quality regulatory submissions while meeting aggressive timelines. Ensure filings are completed in a timely manner, that regulatory content is consistent across development programs, and that sound scientific justification is employed in CMC regulatory strategy.

Essential Duties and Job Functions:

Responsible for the preparation and/or oversight of technically complex clinical and commercial regulatory CMC submissions taking into consideration ICH requirements, regional requirements and scientific and company policies and procedures. May direct others in accomplishing objectives. Provides strategic regulatory advice as appropriate.

Maintains up to date knowledge of regulatory requirements and communicate changes in regulatory information to project teams and senior management in a timely manner. Initiates local process improvements and contributes to local and/or global process improvements, which have a significant impact on the overall efficiency of the regulatory submission process. Plans, schedules, and arranges own activities and those of direct reports.

Knowledge, Experience and Skills:

Advanced degree with focus on Analytical Chemistry or related field is desired, with 20+ years of experience in Analytical Chemistry/Regulatory Affairs. Excellent verbal and written communication skills and interpersonal skills are required. Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements, and understanding of current global and regional trends in Regulatory Affairs. Must be capable of developing and implementing regulatory strategy. Is recognized as a knowledgeable resource for regulatory advice and strategy, and able to collaborate with CMC subteams in the preparation of complex submissions. Must be capable of working independently, and previous management experience 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.

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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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