Gilead Sciences, Inc.
Director, Global Therapeutic Area Regulatory Liaisons - Oncology
Gilead Sciences, Inc., Foster City, California, United States, 94420
Director, Global Therapeutic Area Regulatory Liaisons - Oncology
You will act as the Global or Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic area. You will typically be assigned a portfolio of products or projects or key Gilead assets to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help develop the TA's Regulatory leadership pipeline through coaching and mentoring other Regulatory colleagues. 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.
#J-18808-Ljbffr
You will act as the Global or Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic area. You will typically be assigned a portfolio of products or projects or key Gilead assets to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help develop the TA's Regulatory leadership pipeline through coaching and mentoring other Regulatory colleagues. 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.
#J-18808-Ljbffr