Senior Director, Regulatory Sciences, CMC
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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.Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossibleJob Description:
The Senior Director of CMC Regulatory Sciences (CMC RS) works closely with other PDM functional groups to plan and author high quality regulatory submissions to health authorities. This role manages regulatory submissions that meet aggressive timelines, with content that is consistent across development programs, and established on a sound, scientific basis. The Senior Director develops regulatory submission strategies to manage a product through its life cycle and sunset.Essential Duties:
Knowledge and Skills:
- Author and review technically complex analytical related sections of clinical, marketing authorization applications, post-approval variations, renewals and responses to agency questions, for submissions in local and international markets.
- Work cross functionally to plan and produce high quality regulatory submissions while meeting aggressive timelines
- Ensure regulatory submissions are in line with ICH guidance, local statutory requirements, scientific principles, and business policies and procedures. Ensure consistency is maintained in regulatory submissions across development and commercial projects, and that sound scientific justification is employed in CMC regulatory strategy.
- Coach and develop staff with skills in operational, technical, and regulatory leadership to make good, timely decisions and achieve impactful outcomes.
- Initiate and contribute to process improvements, which have a significant impact on the overall efficiency of the regulatory submission process.
- Support and manage analytical CMC related activities for drug substance and products based on scientific knowledge, control strategies, regulatory and quality compliance.
- Apply up to date knowledge of regulatory and quality compliance requirements, and communicate changes in regulatory information to project teams and management.
- Represent CMC RS in multiple late-stage development, commercial project teams
Education and Experience:
- Knowledge of regulatory requirements, including ICH requirements and regional requirements and have an in-depth understanding of current global and regional trends in technical regulatory affairs.
- People management skills with experience to coach, guide, and develop a high performance team.
- Excellent verbal and written communication skills, and interpersonal skills
- BS, MS, or Ph D with Chemistry or related field, with 15+ years of pharmaceutical industry experience
- Experience in authoring independently without supervision a variety of CMC components of clinical, marketing or post-approval variation submissions, and response to agency questions.
- Experience to coach staffs to author a variety of CMC components of clinical, marketing or post-approval variation submissions, and to coach staffs to support CMC related activities.
- Strong business acumen and experience with CMC requirements for drug development of new molecular entities, with experience in regulatory submissions for clinical or marketing authorization applications for small molecules, as well as biologics and combination products is desirable.
- Ability to develop and implement regulatory submission strategy. Well versed in analytical control strategies for drug substance and drug product.
- Ability to collaborate with cross functional teams in the preparation of complex submissions.
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