Associate Director, Regulatory Affairs, Virology
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
Gilead Regulatory Affairs is a committed and proud team of highly skilled professionals dedicated to helping deliver therapies in the most efficient and effective way to patients with unmet medical need around the world. We bring our passion for science, discovery, and innovative strategic thinking into everything we do. Our advanced regulatory expertise, track record for developing systems and processes, and our commitment to science allow us to play a strategic role as leaders at Gilead and with global regulatory bodies as we seek to develop new therapies for unmet needs.
We are an inclusive and diverse community, which is supported by strong leaders who are committed to providing individual development and growth opportunities while achieving our mission. Our collaborative and supportive structure help support work-life balance for our teams.Position Overview
The Associate Director will serve as the Global Regulatory Lead with the Global Development Team/s and will provide strategic regulatory guidance for assigned programs in the Emerging Viruses (including COVID-19) therapeutic area. 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:
Education & Experience:
- Responsible for preparing and/or overseeing the preparation of technically complex regulatory affairs 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.
- 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, SOP updates, 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).
- Excellent organizational skills and ability to work on and/or oversee a number of 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.
- 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.
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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.
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:
Please log onto your Internal Career Site to apply for this job.To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Associate-Director--Regulatory-Affairs--Virology_R0022175-1
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