Director, Regulatory Affairs
Gilead Sciences · Ireland - Dublin ·
- Category
- Legal
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
Global Therapeutic Area (TA) Regulatory Liaisons is a core function within Gilead's Global Regulatory Affairs (GRA) organisation and serves as a critical strategic partner across drug discovery, development, and commercial teams. Global TA Regulatory Liaisons develop regulatory strategic options and work closely with cross-functional leaders and regulatory authorities to determine appropriate pathways to obtain and maintain licensure and optimal formulary listings. These strategies are essential to securing and maintaining licensure for Gilead's medicinal products, proprietary methodologies, and technologies by managing registrations, regulatory filings, and agency communications and interactions across key markets worldwide.
Gilead's Pediatric Center of Excellence is a global hub based in Dublin, Ireland, dedicated to advancing the research and development of treatments for children living with serious diseases, including HIV, viral hepatitis, COVID-19, and cancer.
The Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence will serve as the Pediatric Regulatory Lead for assigned products and play a key role in developing and executing regulatory strategies, plans, and objectives for pediatric development programmes across the Virology, Oncology, and Inflammation therapeutic areas, aligned with the overall global development strategy for each product. This may include overseeing the development of global pediatric regulatory plans and submissions, monitoring the progress and fulfilment of global pediatric commitments, and guiding and advising colleagues to ensure these activities are completed thoroughly, effectively, and compliantly. The successful candidate will collaborate across multiple functions and partner with global and regional regulatory leaders to explore and advance the use of our medicines as potential treatments for children living with serious diseases.
This role requires the successful candidate to be based in our Dublin office. We will consider suitably qualified candidates from other countries who express an interest, with the understanding that relocation to Dublin would be required and would not be supported by Gilead.
RESPONSIBILITIES
- Accountable for developing, maintaining, and delivering the global pediatric regulatory strategy in alignment with the overall development of a product.
- Provide leadership on pediatric regulatory requirements in major markets (e.g., United States and European Union) and strategic pediatric regulatory guidance in support of global pediatric development and submissions, including the use of regulatory mechanisms to optimise pediatric product development (e.g., Orphan Drug Designation, Fast Track Designation, conditional/accelerated approval, and compassionate use).
- Proactively identify and assess pediatric regulatory risks, including compliance, timing, and execution risks, and work with cross-functional and regulatory partners to define mitigation strategies and address challenges.
- Collaborate with regulatory and cross-functional teams through effective communication and strong regulatory leadership to prepare and coordinate the execution of global pediatric strategies and plans in support of corporate and regulatory goals, align approaches across programmes and therapeutic areas, and incorporate key learnings.
- As needed, represent Gilead in negotiations with regulatory authorities and lead the preparation of regulatory documents, presentations, and discussions for Health Authority meetings.
- Lead with an enterprise mindset and initiate or contribute to global and/or local process improvements and corporate or departmental initiatives.
- Ensure compliance with established practices, policies, processes, and all applicable regulatory requirements.
- Work under consultative direction towards corporate regulatory goals and objectives.
REQUIREMENTS
We are all different, yet we all use our unique contributions to serve patients.
Please see below the qualifications and skills we are seeking for this role.
Education & Experience
- PharmD/PhD, MA/MS/MBA, or BA/BS with significant relevant experience.
- Experience in pediatric drug development is highly desirable, with direct hands-on experience in regulatory procedures and documentation required for pediatric submissions in key regions such as the US and EU. Experience developing and leading regulatory strategies through to successful outcomes is strongly preferred.
- Pharmaceutical industry experience within Regulatory Affairs is strongly preferred.
- Experience across one or more Gilead therapeutic areas and different stages of drug development is strongly preferred.
Knowledge & Skills
- Thorough understanding of pediatric regulatory requirements, including ICH guidelines and regional requirements for major markets, as well as current global and regional Regulatory Affairs trends, with the ability to assess their impact on the business.
- Excellent verbal, written, influencing, negotiation, and interpersonal communication skills.
- Proven ability to manage complex projects, balancing multiple priorities and deliverables through influence and leadership.
- Strong analytical and problem-solving capabilities, demonstrated through professional experience.
- Strong leadership skills with experience guiding, influencing, and leading others towards shared goals.
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:
Please apply via the Internal Career Opportunities portal in Workday.