For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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
 

We are looking for a unique individual who is passionate about advancing therapeutics and thrives under pressure. This is an exciting opportunity for a Manager to join the team based in Seoul reporting to the Director, Regulatory Affairs. The Kite Pharma Regulatory Affairs teams work closely with the Gilead Regulatory Affairs teams allowing for real time knowledge sharing and support across programs.

The successful candidate, as an individual contributor, will:

Regulatory Strategy and Submissions: Define and oversee regulatory strategies to ensure successful submissions adhering to local, regional, and international regulations, which may include Advanced Therapy Medicinal Products (ATMP) and life cycle maintenance in Korea.

Cross-Functional Collaboration: Collaborate with global teams and the broader regulatory community to support clinical development programs, engage in cross-functional initiatives, and represent regulatory interests across diverse stakeholders.

Process Development, Improvement, and Training: Set up and maintain regulatory administrative processes through document management, tracking, and training of new colleagues, while ensuring compliance with established policies and procedures.

Essential Duties and Responsibilities include the following:

Collaborate cross‐functionally to ensure the development and execution of robust regulatory strategies whilst ensuring regulatory compliance.

Support the risk assessments on specific local regulatory issues, anticipating potential impacts and risks and proposing solutions including the probability of success.

Manage regulatory submissions and approvals and all related activities, in collaboration with internal and external stakeholders, ensuring delivery of the regulatory strategy in Korea and other territories (training will be provided) for new applications and life‐cycle management.

Initiate and otherwise support local and global process improvements.

Act as point of contact, in support to the direct manager, with health authorities.

Act as a direct point of contact with trade associations, leading and managing the interactions/meetings.

Participate in or lead, with guidance, departmental and cross‐functional meetings, taskforces and initiatives.

Actively monitor and anticipate trends that impact the regulatory environment and adapt regulatory strategies in a timely manner.

Review and approve promotional materials in accordance with national legislation and Codes of Practice and company policies and procedures.

Support maintenance of GDP, Importer’s and Wholesaler’s license and Quality Agreements related to product lines, including cell/gene therapy product(s).

Responsible for demonstrating Gilead leadership commitments.

Education & Experience:

BSc or MSc in a life sciences or related field with significant regulatory experience (minimum 5 years) in the pharmaceutical/biotechnology industry in Korea.

Extensive knowledge of regulatory requirements in biologicals and in managing close interactions with HA.

Experience in developing complex regulatory strategies and leading regulatory submissions.

Demonstrates strong analytical and critical thinking skills, attention‐to‐detail, strong communication and writing skills and project management skills.

Experience working in project teams, being capable of effectively interact with internal and external parties to information gather and drive projects through to completion to tight timelines.

Skills & Behaviors

Excellent verbal and written English communication skills. Relevant technical language skills will be highly advantageous.

Excellent interpersonal skills are required to work collaboratively across functions on local and global assignments.

Exceptional planning and organizational skills, capable of managing multiple simultaneous projects with tight timelines.

Strong analytical skills with a focus on problem-solving and strategic thinking to influence outcomes.

Self-motivated and enthusiastic, with a commitment to sharing knowledge and educating colleagues while effectively engaging with internal and external stakeholders.

Gilead Core Values

Integrity (Doing What’s Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)

Leadership commitments

I AM BOLD in aspiration and AGILE in execution.

I CARE and make time for people.

I LISTEN, speak openly and explain the "why."

I OWN the impact of my words and actions.

 

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.