Director, Regulatory Affairs CMC
United States - California - La Verne
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.
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to apply for this job.Job DescriptionDirector, Regulatory Affairs CMC
Are you ready to be a strategic leader helping Gilead develop and deliver life-saving therapies? Are you prepared to use your scientific knowledge to play a critical role in leading teams and partnering with internal groups and external agencies as we strive to cure unmet medical needs around the world?
We are looking for a Director of Regulatory Affairs CMC who is ready to dive in and lead teams that make a difference while developing your career. In this high visibility role, you will provide strategic and operational leadership in all CMC regulatory activities related to Gilead's business and therapies. You will work cross-functionally as well as globally.
Gilead is focused on developing life-saving therapies for unmet needs. As a Director, you will be a key leader working with the business and external agencies to help get our therapies approved. You will be a part of an expert and supportive team that fosters constructive collaboration and gives each person a voice.Responsibilities
The Director of Regulatory Affairs CMC will provide strategic and operational leadership in all CMC regulatory activities related to Gilead's business and therapies. You will work cross-functionally as well as globally.
Gilead is focused on developing life-saving therapies for unmet needs. The Director will be a key leader working with the business and external agencies to help get our therapies approved. They will be a part of an expert and supportive team that fosters constructive collaboration and gives each person a voice.Responsibilities
Knowledge, Experience and Skills
- Responsible for leading all regulatory CMC activities for assigned project(s) and territories, in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Oversee submissions (NDA/BLA, IND/IMPD, supplements and variations for US and other assigned territories) that are technically complex and require extensive interaction with departments outside of Regulatory Affairs CMC.
- Responsible for provision of CMC regulatory strategy to all project teams and sub-teams for assigned projects.
- Manage the tactical operations of US-based Regulatory Affairs CMC teams with responsibility for performance management and staff development.
- Responsible for ensuring the development, and execution of strategy to support development programs, new drug applications and key post-approval change control implementation plans for small molecules, and drug-device combination products. Experience in biologics is a plus
- Work across all levels of business within Gilead to communicate complex CMC issues and deliver updates on major CMC regulatory guidance.
- Lead the preparation of risk assessments on major global CMC regulatory issues.
- Maintain current working knowledge of regional and global regulatory requirements, analyze current trends and anticipate changes in the regulatory requirements to adjust strategic plans as appropriate.
- Initiate and contribute to local and/or global process improvements, which have a significant impact for the CMC Regulatory Affairs Department, and the Pharmaceutical Development and Manufacturing organization.
- Use your industry network to maintain an awareness of CMC methodologies and disseminate this information to the business.
- Minimum 12+ years of relevant experience in Regulatory Affairs CMC
- Technical experience within the (Bio-) Pharmaceutical Industry can be partially substituted for Regulatory experience.
- Requires a Bachelor's degree in a relevant scientific discipline. An advanced degree is preferred.
- Must have in-depth knowledge of US regulatory requirements, including ICH. Previous experience of RA-CMC requirements for other ex-US countries is desirable.
- Demonstrated success as a people manager and leader, with strong staff development skills.
- A proven track record of developing global CMC strategies.
- Excellent verbal and written communication and interpersonal skills.
- Demonstrated ability to influence across broader functional disciplines.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.