Great opportunity in the growing Oncology team at Gilead. Opportunity to be a regional regulatory strategic leader in the growing Trodelvy franchise. Lead upcoming filings as well as indication expansion (including Health Authority Meetings and global roll out of studies). Work with talented cross functional teams on this exciting compound that is the key driver for Gilead Oncology in the future.
Knowledge & Skills:
- May serve as a Core member of the cross-functional Project Team (region specific)
- Regional Regulatory Lead on Regulatory Project Team
- Regional Lead and may lead cross-functional /cross-regional Regulatory Submission Teams
- Participates on other Subteams (eg, Clinical, Nonclinical, Biomarkers)
- Serves as contact with local Regulatory Authorities
- Responsible for preparing and/or overseeing the preparation of technically complex regulatory submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products, in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include supplements and license renewals to clinical trial applications and marketing authorizations, and original INDs/CTAs and NDAs/MAAs for assigned territories.
- Provides strategic regulatory advice as appropriate.
- Oversees preparation and maintenance of country specific labeling and product packaging (region specific)
- Ensures up-to-date knowledge of regulatory requirements and communicates changes in regulatory information to project teams and senior management in a timely manner.
- Initiates local process improvements and contributes to local and / or global process improvements, which have a significant impact for the Regulatory Affairs Department or other departments.
- Plans, schedules and arranges own activities and those of direct reports (if applicable).
Education, Skills & Experience:
- Excellent organizational skills and ability to work on and/or oversee several projects with tight timelines
- Excellent verbal and written communication skills and interpersonal skills.
- Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs.
- Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
- Must be capable of assuming leadership role in updating and preparing the Company for minor changes in legislation in assigned territories and of actively participating in a broader cross functional team for implementation of major changes (region specific).
- Must be capable of leading a team in preparation of complex regulatory submissions and maintenance of licenses.
- Work is performed under consultative direction towards corporate regulatory goals and objectives.
- Is recognized as a knowledgeable resource for Regulatory Advice in other departments.
- Has demonstrated ability to act as primary Company contact with Regulatory Authorities. May have experience working with Regulatory Authorities in multiple territories.
- Previous people management experience is desirable.
- 10+ years of experience in Regulatory Affairs or other relevant industry experience with BS/BA
- 8+ 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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