Senior Director, Global Regulatory Strategy Leader (Inflammation)
United States - California - Foster CityUnited States - New Jersey - Morris Plains
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
The Senior Director of Global Regulatory Affairs is a strategy and team leader for at least 1 disease area or franchise within the Regulatory Affairs Inflammation group, leading a team of Global and US regulatory leads (GRLs and USRLs, respectively). The Senior Director is accountable for the development, oversight, execution, and communication of global regulatory strategies in line with the goals for the disease area(s) or franchise within the Inflammation therapeutic area and provides regulatory guidance. The Senior Director will represent regulatory affairs on program strategy teams and other cross-functional global leadership teams as appropriate. The Senior Director reports to the Global Regulatory Strategy Head for Inflammation. Key Responsibilities
Knowledge, Experience and Skills
- Strategy and team leader for at least 1 disease area or franchise
- Accountable for global regulatory strategies for investigational and marketed products in disease area(s) or franchise in line with ICH requirements, local requirements and scientific and company policies and procedures
- People manager of GRLs and USRLs assigned to disease area or franchise
- Represents regulatory affairs on cross functional global leadership teams
- Oversees submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs
- Ensures up-to-date knowledge of regulatory requirements, contributes to preparation of new regulatory guidance, comments on draft regulatory guidance, and communicates changes in regulatory information to project teams and senior management
- Understands current global and regional trends in regulatory affairs and takes a leadership role in assessing and communicating the impact of these requirements to the business
- Initiates or contributes to local and/or global process improvements which have a significant impact on business
- Is recognized as an expert resource for regulatory advice across departments
- Science degree (PhD, PharmD, MD, MSc) with 12+ years; Bachelors Degree with 14+ years of progressively responsible Regulatory Affairs experience within pharma/biotech industry
- Experience as GRL leading major market applications, developing and executing regulatory strategy, and managing negotiations with major health authorities for investigational and/or marketed products
- Preferably managed direct report(s)
- Demonstrated effective verbal, written, negotiation and interpersonal communication skills are required
- Extensive knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories 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
- Proven track record with taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments
- Recognized as an expert resource for Regulatory Advice in other departments
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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
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