Senior Manager, Global Regulatory Affairs Inflammation
Senior Manager, Global Regulatory Affairs Inflammation
United States - California - Foster CityUnited States - New Jersey - Morris PlainsUnited States - Washington - Seattle
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. Gileads 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 companys five core values. Thats 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
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.
- 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
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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 firstname.lastname@example.org 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.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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