Director - Regulatory Affairs CMC - Gilead Sciences - Foster City

Job description
Responsibility for oversight and direction for US based RA-CMC team. This position will have influence with US regional and global responsibility over Gilead’s portfolio across all therapeutic areas. The role will be responsible for creating the Chemistry, Manufacturing and Controls (CMC) global regulatory strategy and be involved in filing regional and global applications for marketed products and development programs. This position will represent CMC Regulatory Affairs at senior level management meetings in various project meetings and in liaising with various regulatory agencies internationally.

• Manages the tactical operations of the US based team with responsibility for performance management and staff development.
• Plans, schedules and arranges own activities and those of direct reports.
• Manages relationships with key stakeholders in Pharmaceutical Development and Manufacturing, Commercial Manufacturing, Quality Operations and across Regulatory Affairs to provide CMC regulatory support in achieving Gilead’s strategic objectives.
• Responsible for ensuring the development and execution of strategy to support global development programs and key post-approval change control implementation plans for small molecules.
• Facilitate the development and submission of technically complex CMC submissions to support global development and commercialization of small molecule programs.
• Able to articulate complex Regulatory Affairs CMC issues; responsible for facilitating the development and submission of CMC content in-line with ICH, regional regulations, scientific requirements, and company policies and procedures.
• Maintains up-to-date knowledge of regional and global regulatory requirements, analyzes current trends and anticipates changes in the regulatory requirements to adjust strategic plans as appropriate.
• Initiates local process improvements and contributes to local and/or global process improvements, which have a significant impact for the Regulatory Affairs Department or other departments.

Desired Skills and Experience
• Requires a Bachelor’s degree in a relevant scientific discipline. An advanced degree is desirable.
• Minimum 14 years of relevant experience in Regulatory Affairs CMC, specifically experience with small molecule programs is required. Additional experience with Biologics programs is preferred. Technical experience within the (Bio-)Pharmaceutical Industry can be partially substituted for Regulatory experience .
• 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 for the US. Previous experience of the RA-CMC requirements for Japan is desirable.
• Demonstrated success as a people manager, with strong hiring and staff development skills.
• Demonstrated ability to influence across wider functional disciplines.

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