Director, Regulatory Affairs

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
 

Specific Education & Experience Requirements:
12+ years of experience in Regulatory Affairs or other relevant industry experience
Degree in a scientific field is preferred.
Specific Job Responsibilities:
Responsible for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidance is met for assigned product(s) and territories.
Prepare and/or manage others’ submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
Responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories.
Responsible for ensuring preparation of the Product Company Core Data Sheets (CCDS), regulatory review of draft Product Company Core Safety Information (CCSI) and ensuring that any updates to the CCDS or CCSI are implemented in a timely manner.
Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license. Acts as project team representative and may act as submission team representative for specified products.
Represents Regulatory Function at internal meetings. Works proactively to build contacts with local Regulatory Authorities. Participates in industry trade groups and regulatory affairs professional societies.
Maintains knowledge of highly complex regulatory requirements up to date, contribute to preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management.
Initiates or contributes to local and / or global process improvements which have a significant impact on the business.
Excellent verbal, written, negotiation and interpersonal communication skills are required.
Must have an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an understanding of current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business.
Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
Excellent influencing and negotiation skills.
Must be capable of taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments.
Must be capable of leading one or more teams in preparation of submissions and maintenance of licenses.
Work is performed under consultative direction towards corporate regulatory goals and objectives.
Schedules and arranges own activities and those of direct report(s) (if applicable).
Is recognized as an expert resource for Regulatory Advice in other departments.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.