Director, Global Regulatory Affairs, Pediatrics

Описание вакансии

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Director, Global Regulatory Affairs, Pediatrics

Dublin, Ireland

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

This is an exciting opportunity to join a Global Regulatory Affairs Pediatric team to develop and implement global regulatory strategic and leadership of regulatory activities for pediatric product development across therapeutic areas.

Specific Education & Experience Requirements:

• Extensive experience in Global Regulatory Affairs (Pharmaceutical industry experience is strongly preferred)

• Advance degree in a scientific field

• Drug development experience and pediatric expertise are required

• Broad experience in early to late stage of product development as well as post-approval phases

• Strong leadership experience

• Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.

Specific Job Responsibilities and required skills:

• Responsible for providing strategic regulatory guidance on the global pediatric development in alignment with and within the overall development of a product.

• Lead multiple projects for the pediatric indication across therapeutical areas and define the regulatory strategy, plans and objectives for the assigned products or projects.

• Accountable for developing a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive pediatric product development and global registrations

• Work on extremely complex problems and provides solutions that have significant impact.

• Ensure guidance on regulatory mechanisms to optimize pediatric product development (e.g. Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use, and pediatric plan) is assessed and incorporated into the global regulatory strategy

• Must 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 and ability to assess the impact of these requirements to the business.

• Experience with regulatory procedures and in developing required documentation for pediatric submissions in key regions with main focus on US and EU.

• Must be able to work with one or more cross-functional core and sub-teams in preparation of submissions, lead preparation of global pediatric plans, compile or review submission documents and correspondence with Health Authorities.

• As needed, represents Gilead in negotiations with regulatory authorities. Oversees contacts for regulatory authorities. Lead preparation of documents, presentations and discussions in Health Autority meetings.

• Attend key regulatory agency meetings which could impact the global product strategy

• Be capable of managing complex negotiations with Regulatory Authorities to guide and support Regional Regulatory team.

• Be capable of advising on a global pediatric strategy considering potential regional differences.

• Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.

• Effectively, proactively, and respectfully communicate and engage project teams to achieve regulatory goals and milestones.

• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

• Work is performed under consultative direction of the Senior Global Regulatory Lead, Pediatrics, towards corporate regulatory goals and objectives.

• Must be able to work in multifunctional teams and be the regulatory voice for strategic project team decisions and in governance teams. Excellent teamwork is required.

• Ability to manage multiple ongoing projects, each at various stages of development.

• Excellent verbal, written, negotiation and interpersonal communication skills are required.

• Schedules and arranges own activities.

• Built trust to be recognized as a knowledgeable resource for Regulatory Advice in other departments.

• Strong negotiation and conflict resolution skills.

• Work in line with company core values

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.

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 careers@gilead.com for assistance.

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