Director, Regulatory Affairs- Oncology
Director, Regulatory Affairs- Oncology
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. 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
* Serves as a Core member of the cross-functional Project Team representing the global regulatory strategy for assigned projects
* Leads Regulatory Project Team for assigned projects
* Leads cross-functional/cross-regional Regulatory Submission Teams and participates on other subteams
* Responsible for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures
* Oversees submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs (e.g. supplements, annual reports, responses to requests for information, original INDs/CTAs and NDAs/MAAs for assigned territories).
* Responsible for development, oversight and communication of global and regional (as applicable) regulatory strategy for assigned projects and regions
* Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation and regulatory guidance is met for assigned product(s) and territories
* Oversees preparation and maintenance of country specific labeling and product packaging (region specific) and ensuring alignment with relevant global Regulatory strategy
* Ensures up-to-date knowledge of highly complex regulatory requirements, contributes to preparation of new regulatory guidances, comments on draft regulatory guidances, and communicates changes in regulatory information to project teams and senior management
* Initiates or contributes to local and/or global process improvements which have a significant impact on the business
* Must have MARKET APPLICATION SUBMISSIONS experience (BLA/NDA/MAA)
* Oncology filing experience including original BLA/NDA is preferred.
* Global filing experience is also preferred.
* Excellent verbal, written, negotiation and interpersonal communication skills are required
* Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities
* Must have an 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
* Must be capable of taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments
* Prepare and/or manage others' submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs
* Must be capable of leading one or more teams in preparation of submissions and maintenance of licenses
* Work is performed under consultative direction towards corporate regulatory goals and objectives
* Schedules and arranges own activities and those of direct report(s) (if applicable)
* Is recognized as an expert resource for Regulatory Advice in other departments
* 12+ years in Regulatory Affairs or other relevant industry experience
* Bachelors degree in a scientific field
* Advanced degree preferred
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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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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