Director, Regulatory Affairs
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
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Director, Regulatory Affairs
Specific Job Responsibilities:
- Serves as a Core member of the cross-functional Project Team representing the global regulatory strategy for assigned projects
- Leads Regulatory Project Team for assigned projects
- Leads cross-functional/cross-regional Regulatory Submission Teams
- Participates on other Subteams
- Oversees contacts for local Regulatory Authorities
- 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
- Oversees submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs (e.g. supplements, annual reports, responses to request for information, original INDs/CTAs and NDAs/MAAs for assigned territories)
- Responsible for development, oversight and communication of global and regional (as applicable) regulatory strategy for assigned projects and regions
- Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation and regulatory guidance is met for assigned product(s) and territories
- Oversees preparation and maintenance of country specific labeling and product packaging (region specific) and ensuring alignment with relevant global Regulatory strategy
- Ensures up-to-date knowledge of highly complex regulatory requirements, contributes to preparation of new regulatory guidances, comments on draft regulatory guidances, 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 be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities
- 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 taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments
- Prepare and/or manage others’ submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs
- 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
- Previous people management experience is required
Education and Experience:
- 12+ years of experience in Regulatory Affairs or other relevant industry experience with BS/BA
- 10+ years of experience in Regulatory Affairs or other relevant industry experience with advanced degree
- Degree in a scientific field is preferred.
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Job posted: 2020-07-28