Manager, Reg Affairs - Inflammation

Manager, Reg Affairs - Inflammation
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible



The Manager will serve as the US regulatory lead and provide strategic regulatory guidance for assigned product(s) in the Inflammation therapeutic area, including marketed and/or investigational product(s). She/he will represent Regulatory Affairs at cross-functional team meetings and will serve as the primary contact with the FDA for the assigned project(s).

Job Responsibilities:

• Responsible for developing regulatory strategy for assigned project(s), and proactively identifying risks/issues and developing mitigation and/or contingency plans
  
• Responsible for leading the preparation, compilation, and the timely filing of regulatory submissions which require interaction with departments outside of Regulatory Affairs for investigational product(s). Examples include meeting requests, briefing packages, original IND, IND amendment, and routine submissions (e.g., DSURs, IB updates, etc.)
  
• Lead cross-functional teams in the authoring of regulatory documents including meeting requests, Module 1 documents for original IND
  
• Critically review documents for submission to regulatory authorities
  
• Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams
  
• Participates on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers)
  
• Initiates or contributes to local and/or global process improvements which have a significant impact on the Regulatory Affairs function or other departments
  
• Work is performed under minimal direction and supervision from a Senior Regulatory Affairs professional
  

Minimum Qualifications:

• 7+ years of experience in Regulatory Affairs or other relevant industry experience with BS/BA
  
• 5+ years of experience in Regulatory Affairs or other relevant industry experience with advanced degree
  
• Degree in a scientific field is preferred
  
• Must have demonstrated strategic and critical thinking with ability to execute
  
• Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements and understand the 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 leading small teams in execution of strategy
  
• 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 and/or oversee several projects under tight timelines
  
• Excellent verbal and written communication skills and interpersonal skills require
  
• Experience as Regional Regulatory Lead managing product(s) and representing Regulatory Affairs on cross-functional teams is required
  

For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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