Manager, 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.
Regulatory Affairs Manager in support of programs in the HIV therapeutic area, including products in early and late phase (Phase 2 and 3) development.
- Responsible for leading all regulatory activities for assigned projects in line with ICH requirements, regional requirements, and scientific and company policies and procedures
- May serve as the Regional Regulatory Lead on Regulatory Project Team
- Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams
- Participates on other Sub-teams (eg, Study Management, Clinical, Nonclinical, Biomarkers)
- May serve as contact with local Regulatory Authorities
- Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs
- Maintains knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information
- Initiates or contributes to local and/or global process improvements which have a significant impact on business
- Plans, schedules, and arranges own activities
- Work is performed under direction of a Senior Regulatory Affairs professional
Education, Professional Experience, and Skills:
- 5+ years of experience in Regulatory Affairs or other relevant industry experience with BS/BA or advanced science degree (PhD, PharmD, MD, MSc)
- Experience as Regional Regulatory Lead managing investigational and marketed products and representing Regulatory Affairs on cross-functional teams is desirable
- Ability to act as primary Company contact with Regulatory Authorities
- Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements 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 strategies and of managing negotiations with regulatory authorities
- Must be capable of reviewing technical documents and influencing colleagues across functions
- Must be capable of effectively leading teams in preparation of submissions
- Excellent organizational skills and ability to work on a number of projects under tight timelines
- Excellent verbal and written communication skills and interpersonal skills required
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Job posted: 2020-07-28