Sr Manager, Regulatory Affairs
Sr Manager, Regulatory Affairs
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 Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we create possible by researching, developing and delivering deliver life-saving therapies in Inflammation, Virology, and Oncology to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs by creating possible for patients with life-threatening diseases.
Sr Regulatory Affairs Manager in support of programs in the Inflammation Therapeutic Area
- Responsible for preparing and submitting moderately complex regulatory documents which require interactions 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
- May provide regulatory expertise to submission teams on specified projects and topics
- May serve as the Regional Regulatory Lead on Regulatory Project Team
- Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams
- May assist in developing and managing gantt charts and trackers for submissions across the multiple products
- May participate on other Sub-teams (eg, Study Management, Clinical, Nonclinical, Biomarkers)
- May serve as contact with local Regulatory Authorities
- Maintains knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information
- Initiates or contributes to local and/or global process improvements which have a significant impact on business
- Plans, schedules, and arranges own activities
- Work is performed under direction of a Senior Regulatory Affairs professional
Education, Professional Experience, and Skills:
- 8 years of experience in Regulatory Affairs or other relevant industry experience with BS/BA or 6 years' 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 is desirable
- 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 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 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 a number of 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.
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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