Director, Global Regulatory Affairs, Pediatrics
5 months ago
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.
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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