Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we are creating possible by seeking to improve the care of patients living with life-threatening diseases around the world. Gilead’s areas of focus include virology, oncology, and inflammation.

We are recruiting for a Senior Manager in Global Regulatory Affairs, Therapeutic Group – Inflammation to serve as a global and/or US/regional regulatory lead.  The Senior Manager is responsible for the development, execution, and communication of regulatory strategies for investigational drug candidate(s) in line with the goals of the rheumatology and gastroenterology disease area(s) within the Inflammation therapeutic area and provides regulatory guidance. The Senior Manager will represent regulatory affairs on cross-functional development program and/or other teams as appropriate. The Senior Manager reports to Senior Director, Global Regulatory Strategy Leader for the Rheumatology and Gastroenterology disease areas within the Inflammation therapeutic area.   

Key Responsibilities:

Global and/or US/regional regulatory lead

Responsible for developing, executing, and communicating regulatory strategies in line with goals of Inflammation therapeutic area  

Responsible for preparing and submitting regulatory documents in line with ICH requirements, regional requirements, and scientific and company policies and procedures

Represent regulatory affairs and participate on cross-functional development program and/or other teams, including sub-teams (regulatory, study management, clinical, and/or biomarkers)

Lead contact with local Regulatory Authorities, based on responsibilities and as appropriate

Maintains up-to-date knowledge of regulatory requirements, contributes to preparation of new regulatory guidance where appropriate, and communicates changes in regulatory information

Initiates or contributes to local and/or global process improvements which have a significant impact on business

Education, Professional Experience, & Skills:

8 years of experience in Regulatory Affairs or other relevant industry experience with BS/BA or 6 years of experience with 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

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 understand 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 several projects under tight timelines

Excellent verbal and written communication skills and interpersonal skills required