Manager, Pediatric Regulatory Affairs
Manager, Pediatric Regulatory Affairs
Ireland - Dublin
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
This is an exciting opportunity to join Virology Regulatory Affairs where you will provide strategy and execution support to the Global Regulatory Lead for pediatric product development.
Specific Job Responsibilities:
- Responsible for supporting the strategic development of global pediatric submissions, including those required in the US and EU.
- Responsible for executing all pediatric-related regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Prepare submissions that are technically complex and require extensive interaction with Regulatory Regional Leads and departments outside of Regulatory Affairs.
- May be required to represent Regulatory at internal meetings and in conjunction with the Global Regulatory Lead and/or Regulatory Regional Lead, at meetings with regulatory authorities.
- Maintains knowledge of regulatory requirements, contribute to the preparation of new pediatric regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams.
- Contributes to local and/or global process improvements which have a significant impact on the business.
- Excellent verbal, written, negotiation and interpersonal communication skills are required.
- Desirable to have hands-on knowledge of pediatric regulatory requirements, including ICH requirements and regional requirements for assigned territories and an understanding of current global and regional trends in Regulatory Affairs.
- Demonstrate capability to develop and execute upon regulatory strategy and of managing negotiations with Regulatory Authorities.
- Excellent influencing and negotiation skills.
- Work is performed under consultative direction of the Global Regulatory Lead, Pediatrics, towards corporate regulatory goals and objectives.
- Schedules and arranges own activities.
- Is recognized as a knowledgeable resource for Regulatory Advice in other departments.
Specific Education & Experience Requirements:
- 7+ years of experience in Regulatory Affairs or other relevant industry experience with BS/BA
- 5+ years of experience in Regulatory Affairs or other relevant industry experience with advanced degree
- Degree in a scientific field is preferred
- Pediatric drug development experience is preferred
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Ireland---Dublin/Manager--Pediatric-Regulatory-Affairs_R0017503-1
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