Sr Director, Regulatory Affairs

Gilead Sciences•Foster City, CA

3d•$243,100 - $314,600•Hybrid

About The Position

Located in Foster City, CA - this is a hybrid (3 days onsite) role. As a Sr Director, Regulatory Affairs at Gilead, you will... Responsible for leading and providing strategic input to 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 leading a team of Regulatory professionals supporting both early phase and marketed products. Responsible for ensuring responsibilities of Applicant and/or Marketing Authorization Holder defined in legislation or regulatory guidance's are met for assigned product(s) and territories. 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. Prepare and/or manage others’ submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs. Responsible for ensuring regional product labeling follows the Company Core Data Sheets (CCDS) and 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 marketing authorization. May act as regulatory project team representative for specified products. Represents Regulatory function at internal and external meetings. Participates in industry trade groups and regulatory affairs professional societies where applicable. Maintains knowledge of complex regulatory requirements, contributes 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. Deputizes effectively and reliably for Executive Director International Regulatory Affairs within the Company and with Regulatory Authorities. Initiates or contributes to local and / or global process improvements which have a significant impact on the business.

Requirements

Excellent verbal and written communication skills and demonstration of excellent interpersonal skills are required.
Excellent influencing and negotiation skills.
Excellent leadership and people management skills, in terms of management of workload, training and development of direct reports are required.
Schedules and arranges own activities and those of direct report(s).
Excellent organizational skills and ability to ensure a multitude of tasks are appropriately delegated, managed and completed.
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.
Proven track record of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
Demonstrated success in leading one or more teams in preparation of submissions and maintenance of marketing authorizations.
Work is performed under consultative direction towards corporate regulatory goals and objectives.
Is recognized as an expert resource for Regulatory Advice in other departments.
Bachelor's degree in a relevant discipline (an advanced degree is highly desirable), with 14+ years of regulatory affairs experience or master's degree in the related areas with 12+ years of regulatory affairs experience.
HIV or drug development experience highly desirable.
Previous people management experience and direct experience working with Regulatory Authorities in assigned territories is required.

Nice To Haves

an advanced degree is highly desirable
HIV or drug development experience highly desirable

Responsibilities

Leading and providing strategic input to all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Leading a team of Regulatory professionals supporting both early phase and marketed products.
Ensuring responsibilities of Applicant and/or Marketing Authorization Holder defined in legislation or regulatory guidance's are met for assigned product(s) and territories.
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.
Preparing and/or managing others’ submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
Ensuring regional product labeling follows the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI), and ensuring that any updates to the CCDS or CCSI are implemented in a timely manner.
Ensuring product packaging and associated information is updated and maintained in accordance with the marketing authorization.
Acting as regulatory project team representative for specified products.
Representing the Regulatory function at internal and external meetings.
Participating in industry trade groups and regulatory affairs professional societies where applicable.
Maintaining knowledge of complex regulatory requirements, contributing to preparation of new regulatory guidance wherever possible, commenting on draft regulatory guidance and communicating changes in regulatory information to project teams and senior management.
Effectively and reliably deputizing for the Executive Director International Regulatory Affairs within the Company and with Regulatory Authorities.
Initiating or contributing to local and / or global process improvements which have a significant impact on the business.