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
Company Overview
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.
Position Overview
Senior Manager CMC regulatory is a key player for regional CMC related activities, responsible for leading / Managing both for commercial and development product in align with global strategy. Also this position is requested to support regional clinical regulatory activities.
Specific Responsibilities:Lead development and life cycle management submissions.
Function as the Regulatory CMC lead on project and submission teams by applying advanced knowledge of regulations and interpret technical regulatory guidelines to ensure regulatory submissions are in compliance with applicable regulations
Strategize on deliverables to ensure M 1, 2 and 3 contents meet regulatory requirements and projected business timelines
Identify CMC risk areas and develop alternative courses of actions including anticipation of regulators responses through scenario planning and development of contingency plans
Align CMC regulatory strategy to overall regulatory business strategy (e.g., process, raw material, shelf-life and analytical changes)
Responsible for assessment of all CMC related changes associated product, process and facilities/ equipment
Provide regulatory CMC expertise during due diligence and in support of new projects
Provide leadership to rapidly adapt strategy to unanticipated changes
Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation necessary for timely submission of applications
Support regional clinical regulatory activities such as submission dossier development and publications in collaboration with Clinical Regulatory function
Minimum Education and Basic Qualifications:Advanced scientific degree (i.e., MD, PharmD, PhD) and 5+ years of regulatory experience OR
Master’s Degree and 8+ years of regulatory experience OR
Bachelor’s Degree and 10+ years of regulatory experience
Preferred Qualifications:8+ years of experience in CMC regulatory, and/or relevant pharmaceutical industry
In-depth knowledge and experience in cell and gene therapy
Experience in documentation for Quality, Non-Clinical safety and Cartagena act related consultation
In-depth knowledge of CMC regulatory requirements for ATMPs and/or biological medicinal products and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products
An in-depth knowledge of ICH requirements, and an understanding of current global trends in CMC Regulatory Affairs
In-depth understanding of cGMP/GCTP requirements of manufacturing facilities and equipment in support of clinical and commercial productions, as well as proven experience in supporting regulatory inspections
A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions
Experience in authoring technical content of regulatory submissions and capable of leading a CMC sub-team in preparation of submissions
Any experience and knowledge of Clinical regulatory affairs activities and/or willingness to assist Clinical regulatory activities are preferred
Organizational skills – detail oriented and can deal with frequent changes in product activity
Excellent interpersonal, verbal and written communication skills in both Japanese and English are essential in this collaborative work environment
High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
Willingness to think outside of the box and adapt best practices to our growing environment
Ability to adapt in a constantly evolving environment
Self-motivated with a strong sense of ownership in areas of responsibility
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Team player and a self-starter with the ability to work with no immediate direction from a senior regulatory affair professional
People Leader Accountabilities:Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.