About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. For over 35 years, Gilead has pioneered breakthroughs in treating HIV, viral hepatitis, COVID-19, cancer, and inflammatory diseases. Our innovative therapies have transformed lives, ensuring access to cutting-edge treatments worldwide. With a relentless focus on collaboration, determination, and scientific excellence, Gilead's teams drive life-changing discoveries in oncology, immunology, and beyond. Headquartered globally with a strong presence in Japan, Gilead fosters an inclusive culture where every employee contributes to bold ambitions.

Role Overview

The Associate Director, Regulatory Affairs CMC position in Tokyo, Japan, is a pivotal leadership role within Gilead's Regulatory Affairs team. As Regional Regulatory Lead, you will spearhead CMC strategies for investigational and commercial products, ensuring compliance with ICH guidelines and Japanese regulations. This role involves serving as a core member of cross-functional Product Development and Management (PDM) teams, leading regulatory submission teams, and acting as the primary contact with local Regulatory Authorities like PMDA. Ideal for seasoned professionals passionate about advancing Gilead's pipeline in HIV therapies, oncology drugs, and treatments for inflammatory diseases, this position offers the chance to make a direct impact on global health.

Strategic Impact

In this role, you will develop and implement regulatory strategies that navigate complex submissions, from Clinical Trial Notifications (CTNs) to marketing authorizations. Your expertise will shape Gilead's regional approach, coordinating with affiliates and global teams to align on labeling, packaging, and process improvements.

Key Responsibilities

As Associate Director, Regulatory Affairs CMC, your core duties include:

• Overseeing the preparation of technically complex CMC submissions, such as supplements, license renewals, and CTNs for assigned territories.
• Providing expert strategic advice on regulatory CMC matters to cross-functional project teams and senior management.
• Coordinating regional CMC strategies, facilitating local meetings, and ensuring compliance with evolving ICH and regional requirements.
• Serving as the key liaison with Japanese Regulatory Authorities, managing negotiations and interactions.
• Maintaining country-specific labeling and product packaging while initiating process improvements with significant departmental impact.
• Keeping abreast of regulatory changes and communicating updates timely to stakeholders.

Qualifications & Requirements

To excel in this role, candidates need:

• Extensive experience in regulatory CMC for biopharmaceuticals, particularly in Japan, with in-depth knowledge of ICH, PMDA, and global trends.
• Proven ability to lead teams in preparing complex submissions and handling negotiations with authorities.
• Excellent organizational, communication, and interpersonal skills to manage multiple projects under tight deadlines.
• Capability to drive process improvements and adapt to legislative changes.
• Experience in cross-functional leadership and oversight of computerized systems is highly desirable.

A bachelor's or advanced degree in a relevant scientific field, combined with 10+ years in regulatory affairs CMC, positions you for success.

Benefits & Perks

Gilead Sciences offers a premium compensation package tailored for top talent in Tokyo:

• Competitive salary estimated at 18-30 million JPY annually, with performance bonuses.
• Comprehensive health insurance, including medical, dental, and mental wellness support.
• Generous paid time off, flexible working arrangements, and family leave policies.
• Retirement savings plans and employee stock purchase programs.
• State-of-the-art facilities and access to cutting-edge technologies in a collaborative environment.

Career Growth

At Gilead, career progression is a priority. As a People Leader, you will develop skills to foster inclusive teams, driving cultural evolution. This role opens doors to global opportunities, with mentorship from senior executives and tailored development programs. Many associates advance to Director or VP levels, contributing to Gilead's ambitious goals in HIV, oncology, and inflammatory disease innovation.

Why Join Gilead

Joining Gilead means becoming part of a mission-driven organization tackling the world's biggest health challenges. In Tokyo, you'll collaborate with diverse experts, leveraging Gilead's legacy in antiviral therapies and expanding oncology portfolio. Enjoy a supportive culture emphasizing inclusion, empowerment, and impact. Help create possible—together—by bringing therapies to patients faster and more effectively.

Role FAQs

Q: Is this a leadership role?
A: Yes, it may involve managing direct reports and leading cross-functional teams.

Q: What regulatory experience is required?
A: In-depth knowledge of CMC regulations in Japan and ICH guidelines, with experience in submissions and authority interactions.

Q: Does Gilead support work-life balance?
A: Absolutely, with flexible schedules, wellness programs, and a focus on employee well-being.

Q: How does this role contribute to Gilead's mission?
A: By ensuring regulatory success for therapies in HIV, cancer, and inflammatory diseases, accelerating patient access.

Q: What is the application process?
A: Submit your resume via Gilead's careers portal; selected candidates proceed to interviews with the Regulatory team.