Director, Regulatory Affairs (Paediatric GRL)
Director, Regulatory Affairs (Paediatric GRL)
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 HIV and Emerging Viruses Regulatory Affairs where you will provide global regulatory strategic and technical leadership of regulatory activities for pediatric product development.
Specific Education & Experience Requirements:
- Extensive experience in Regulatory Affairs or other relevant industry experience with BS/BA
- Significant level 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 required
Specific Job Responsibilities:
- Responsible for providing strategic regulatory guidance on the development of global pediatric submissions, including those required in the US and EU.
- Responsible for leading 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.
- Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidance for pediatric products is met for assigned product(s) and territories.
- Prepare and/or manage others' submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
- Represents Regulatory at internal meetings and in conjunction with the local regulatory liaison, at meetings with regulatory authorities.
- Maintains knowledge of highly complex regulatory requirements up to date, contribute to preparation of new pediatric regulatory guidance wherever possible, comments on draft regulatory guidance 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.
- Excellent verbal, written, negotiation and interpersonal communication skills are required.
- Must have extensive 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 and ability to assess the impact of these requirements to the business.
- Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
- Excellent influencing and negotiation skills.
- Must be capable of taking a leadership role in updating and preparing the Company for major changes in pediatric legislation in assigned territories, which impact many departments.
- Must be capable of leading one or more teams in preparation of submissions.
- 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.
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies 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 and improve life by advancing the care of patients with life-threatening diseases.
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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