Associate Director, Regulatory Affairs, Liaison (Oncology)
- Job Type
Associate Director, Regulatory Affairs, Liaison (Oncology)
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
Great opportunity in the growing Oncology team at Gilead. Opportunity to be a regional regulatory strategic leader in the growing Trodelvy franchise. Lead upcoming filings as well as indication expansion (including Health Authority Meetings and global roll out of studies). Work with talented cross functional teams on this exciting compound that is the key driver for Gilead Oncology in the future.
** This role can be based out of Foster City, CA / Seattle, WA / Morris Plains, NJ.**
- May serve as a Core member of the cross-functional Project Team (region specific)
- Regional Regulatory Lead on Regulatory Project Team
- Regional Lead and may lead cross-functional /cross-regional Regulatory Submission Teams
- Participates on other Subteams (eg, Clinical, Nonclinical, Biomarkers)
- Serves as contact with local Regulatory Authorities
- Responsible for preparing and/or overseeing the preparation of technically complex regulatory submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products, in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include supplements and license renewals to clinical trial applications and marketing authorizations, and original INDs/CTAs and NDAs/MAAs for assigned territories.
- Provides strategic regulatory advice as appropriate.
- Oversees preparation and maintenance of country specific labeling and product packaging (region specific)
- Ensures up-to-date knowledge of regulatory requirements and communicates changes in regulatory information to project teams and senior management in a timely manner.
- Initiates local process improvements and contributes to local and / or global process improvements, which have a significant impact for the Regulatory Affairs Department or other departments.
- Plans, schedules and arranges own activities and those of direct reports (if applicable).
Knowledge & Skills:
- Excellent organizational skills and ability to work on and/or oversee several projects with tight timelines
- Excellent verbal and written communication skills and interpersonal skills.
- Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs.
- Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
- Must be capable of assuming leadership role in updating and preparing the Company for minor changes in legislation in assigned territories and of actively participating in a broader cross functional team for implementation of major changes (region specific).
- Must be capable of leading a team in preparation of complex regulatory submissions and maintenance of licenses.
- Work is performed under consultative direction towards corporate regulatory goals and objectives.
- Is recognized as a knowledgeable resource for Regulatory Advice in other departments.
- Has demonstrated ability to act as primary Company contact with Regulatory Authorities. May have experience working with Regulatory Authorities in multiple territories.
- Previous people management experience is desirable.
Education, Skills & Experience:
- 10+ years of experience in Regulatory Affairs or other relevant industry experience with BS/BA
- 8+ years of experience in Regulatory Affairs or other relevant industry experience with advanced degree
- Degree in a scientific field is preferred.
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 firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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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