Manager, Regulatory CMC

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.
 

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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 seeking an experienced Regulatory CMC Manager to lead and execute regulatory CMC activities in support of both commercial and clinical-stage Kite Cell Therapy programs across Asia, with primary responsibility for South Korea and additional support for Taiwan and Singapore as needed.

This role is a key regional contributor responsible for ensuring regulatory compliance, driving CMC regulatory strategy, and enabling timely submissions and lifecycle management activities through close collaboration with global and local cross‑functional teams.

Key Responsibilities

(include but are not limited to)

• Lead operational and lifecycle management activities for Regulatory CMC submissions (e.g., IND, IMPD, BLAA, MAA) supporting both clinical development and commercial Kite Cell Therapy products, including global and regional harmonization of CTD Module 3 and Module 1.

• Serve as the local Regulatory CMC lead on cross‑functional program teams, applying in‑depth regulatory knowledge to interpret and implement global and local CMC regulatory requirements.

• Lead Health Authority interactions related to CMC matters, including preparation, coordination, and submission of responses to regulatory questions; proactively engage in discussions and negotiations with MFDS and other local authorities as appropriate, ensuring alignment with ICH and local guidelines.

• Define and execute CMC regulatory strategies to ensure Module 3 and Module 1 content meets regulatory expectations and aligns with business and development timelines.

• Identify potential CMC regulatory risks and develop mitigation strategies, including scenario planning and contingency approaches based on anticipated regulatory feedback.

• Ensure alignment of CMC regulatory strategy with broader regulatory and business strategies, including changes related to manufacturing processes, raw materials, specifications, analytical methods, and shelf‑life.

• Assess and determine appropriate regulatory CMC reporting pathways for CMC changes in accordance with local regulations and requirements.

• Coordinate and author high‑quality CMC regulatory documentation in collaboration with global Regulatory CMC, Technical Operations, Quality, and other cross‑functional partners.

Required Qualifications

Basic Qualifications

• Bachelor’s degree in a scientific or technical discipline.

• 5+ years of relevant experience in Regulatory CMC and/or drug development.

Required Skills and Experience

• Fluent in Korean and English, with strong written and verbal communication skills.

• Demonstrated hands‑on experience with MFDS Regulatory CMC submissions.

• High proficiency in technical translation of Regulatory CMC content between Korean and English.

• Strong organizational skills with attention to detail; ability to manage multiple activities in a dynamic environment.

• Excellent interpersonal, written, and verbal communication skills, with the ability to work effectively in cross‑functional and multicultural teams.

• Proficiency with industry‑standard software tools (e.g., MS Word, MS Office, Adobe).

Personal Attributes

• Self‑motivated with a strong sense of ownership and accountability.

• Comfortable operating in a fast‑paced, evolving environment with changing priorities.

• Demonstrates professionalism, integrity, and sound judgment.

• Flexible, solution‑oriented mindset with the ability to adapt best practices within a growing organization.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.