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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

KEY RESPONSIBILITIES 

The Senior Director, CMC Regulatory Affairs – Japan is responsible for managing a team of professionals responsible for Gilead’s Japan global portfolio of products in CMC Regulatory Affairs, which is part of the broader Pharmaceutical Development & Manufacturing (PDM) organization.  This position will lead a Japan CMC RA team that ensures “right first time” global approvals of CMC regulatory submissions (clinical and commercial), and “right to operate” by maintaining the global licensures. In addition, the leader will be recognized as a thought leader for Japan regulatory science and be accountable for leading the interpretation and implementation of CMC regulatory guidelines, ICH, regulations, and current environment to assure approvability in Japan.  The role will report directly to the Head of CMC Regulatory Affairs, International based in Cambridge, UK.  

JOB DESCRIPTION 

• Lead a Japan CMC RA team to support the support the registration and maintenance of commercial products in Japan.  
• Partner with PDM to lead development and life cycle management aspects of Japan regulatory CMC submissions.  
• Ensure/defend CMC dossiers to meet ICH content requirements, as well as the specific local requirements. 
• Take a leadership position in conducting Japan-specific risk assessments on major global CMC regulatory issues and provide guidance to corporate management. 
• Work (matrix) with the CMC RA Policy Office to proactively to build/maintain contacts with the PDMDA, and to present a positive image of Gilead in all discussions with the health authority. 
• Responsible for ensuring timely discussion with Japan authorities regarding responses to questions and work with international colleagues to ensure consistency of responses to international Health Authorities (using ICH as the foundation). 
• Identify Japan CMC risk areas and develop alternative courses of actions including anticipation of regulators responses through scenario planning and development of contingency plans. 
• Lead the execution of the Japan CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development. 
• Lead/advise Japan regulatory strategies and solutions for complex CMC challenges for all Gilead product submissions and commercial registrations, including risk mitigation. 
• Engage PMDA in the interpretation and implementation of ICH guidelines, with a goal of an approved/harmonized regulatory control strategy. 
• Ensure regulatory conformance and consistency for Gilead products in Japan in compliance with regulatory requirements and internal procedures. 
• Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead to develop understanding and build CMC registration strategy for Japan. 
• Promote the use of novel approaches in Japan within project teams to resolve issues and problems. 
• Develop meaningful and collaborative relationships with PMDA and the Japan Pharmaceutical Manufacturers Association (JPMA). 
• Assess risks and develop contingency plans, including major, complex applications in Japan in partnership with PDM and RA Japan. 
• Demonstrate and model Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities; Embrace and comply with global CMC principles of integrity. 

QUALIFICATIONS 

• A scientific degree with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs, and CMC technical areas of at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, PharmD, or MD.   
• Extensive experience working with PMDA. 
• Drug-device combination product experience would be an advantage. 
• Demonstrated track record in defining innovative CMC regulatory strategies and implementing at a platform level. 
• Leadership in Japan regulatory/industry forums for topics of external policy relevance (e.g., ICH, JPMA, ISPE, IQ, Bios, etc.). 
• Experience with leading JNDA submission and approvals, including global Health Authority interactions. 
• Demonstrated success in influencing without positional authority within a highly matrixed organization. 
• An in-depth knowledge of ICH requirements, and an understanding of current global trends in CMC Regulatory Affairs. 
• Application of sound and accurate judgment to make timely decisions. 

• Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives. 
• Demonstrated organizational leadership skills at functional level. 
• Excellent strategic acumen, collaboration, and communication skills are required. 
• Demonstrated commitment to inclusion, developing talent and empowering teams. 

Gilead Core Values  

• Integrity (Doing What’s Right)  
• Inclusion (Encouraging Diversity)  
• Teamwork (Working Together)  
• Excellence (Being Your Best)  
• Accountability (Taking Personal Responsibility) 

Equal Opportunities
As an equal opportunity employer, Gilead Sciences 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 laws. It is also Gilead’s policy to comply with all applicable laws respecting consideration of unemployment status in making hiring decisions.

For Current Gilead Employees and Contractors:

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