Senior Regulatory Affairs Manager

Reposted 2 Days Ago
Be an Early Applicant
Tokyo, JPN
In-Office
Senior level
Biotech
The Role
The Senior Regulatory Affairs Manager will represent regulatory affairs, define regulatory strategy, manage regulatory submissions, lead cross-functional teams, and ensure compliance with regulations.
Summary Generated by Built In

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
 

•    Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams. 
•    With guidance, defines the regulatory strategy for one or more Gilead/Kite products or projects. 
•    Evaluates changes to the local regulatory landscape and sharing risks and opportunities with the global study team when necessary.
•    Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans. 
•    Leads the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Clinical Trial Notification (CTN). 
•    Leads cross-functional teams in the authoring of regulatory documents, including meeting requests, Module 1 documents for new drug submission, etc. 
•    Provides input to the content of the original label and label updates. 
•    Ensures product packaging and associated information is updated and maintained in accordance with the product license for assigned products and markets. 
•    Contributes to process improvements and/or other special projects within Regulatory Affairs. 
•    Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.


 


For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Skills Required

  • Experience in regulatory affairs or related fields
  • Ability to interact cross-functionally
  • Strong organizational skills

Gilead Sciences Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Gilead Sciences and has not been reviewed or approved by Gilead Sciences.

  • Fair & Transparent Compensation Pay is considered competitive and fair relative to roles, frequently cited as a standout strength. Feedback suggests compensation compares well within biotech and is a notable reason employees feel valued.
  • Equity Value & Accessibility Stock awards and an employee stock purchase program are consistently described as meaningful parts of total compensation. Equity components are seen as accessible and enhance long‑term wealth building.
  • Retirement Support A strong company 401(k) match with immediate vesting is often singled out as a differentiator. This support is perceived to significantly boost long‑term financial security.

Gilead Sciences Insights

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The Company
HQ: Foster City, CA
14,337 Employees
Year Founded: 1987

What We Do

The way we see it, the impossible is not impossible. It’s simply what hasn’t been achieved yet. For more than 30 years, we’ve pursued it, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Creating Possible drives everything we do. It’s evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving lives of people around the world. For us, nothing is impossible – because of the people we work with, the communities we stand with and the partners we push forward with. Our ~12,000 employees band together through science, grit, compassion and courage to prove the impossible wrong. At Gilead, the tangible results of your contributions are evident. Where every individual matters. Where all employees can enhance their skills through ongoing development. And where we start every day with one question: “What’s next?” Social Media Guidelines: https://gilead.inc/3t1m7d5

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