Regulatory Affairs Associate Director

Bachelor of Business Administration (Management)

Nationality: Any Nationality

Vacancy: 1 Vacancy

Job Description

For Current Gilead Employees and Contractors:

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At Gilead, we are 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 of 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 fulfill their aspirations. Join Gilead and help create possible, together.

Regulatory Affairs Associate Director, Gulf Countries, based in the UAE

We are looking for a unique individual who is passionate about advancing therapeutics, with creative problem-solving skills to seamlessly meet the business needs while maintaining regulatory compliance. This is an exciting opportunity for an Associate Director to join the Regulatory Affairs team built on a strong sense of teamwork and excellence. The position is based in the UAE, reporting to the Director of Regulatory Affairs, Middle East Region. The successful candidate will lead the regulatory strategy and execution plan for Gilead's portfolio in Gulf Countries.

The role involves close cross-functional collaboration with a diverse number of stakeholders both internally and externally to:

• Lead the definition, setting, and oversight of regulatory strategies to maximize regulatory success towards achievement of the program objectives, in conjunction with local, regional, and global teams.
• Provide strategic and tactical advice to achieve timely and efficient regulatory submissions, including new applications and life cycle maintenance activities, while ensuring compliance with applicable regulatory requirements and internal policies and standards.
• Engage with the broader Regulatory community within Gilead and contribute to cross-functional initiatives representing the regulatory function and interacting with a diverse number of stakeholders.

Primary Responsibilities

• Lead regulatory submissions for new applications and life cycle maintenance in Gulf Countries, in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, regional requirements, and scientific and company policies and procedures.
• Accountable for regulatory submissions and approvals and all related activities, in collaboration with internal and external stakeholders, ensuring delivery of the regulatory strategy.
• Ensure project team colleagues, line management, and key stakeholders are appraised of developments that may impact regulatory success, exercising sound judgment and communicating in a timely manner.
• Responsible for anticipating and quantifying risks and proposing solutions with the probability of success.
• Be accountable for establishing strong working relationships with the RA Therapeutic liaisons/regulatory central team, other functions as required, and including distributors to ensure global regulatory submissions are provided to local representatives in compliance with local regulations and to maintain compliance.
• Participate in or lead departmental and cross-functional taskforces and initiatives.
• Facilitate manufacturing sites registration, in line with national requirements.
• Point of contact at the cross-functional and project team meetings.
• Be responsible for demonstrating Gilead leadership commitments.

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