Director, Regulatory Sciences
Foster City, CA, USA | Gilead Sciences
Industry:Pharmaceutical / Biotech
Job Description:90 people have viewed this job
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.
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