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About the Role
Gilead is dedicated to creating a healthier world by tackling diseases like HIV, viral hepatitis, COVID-19, and cancer through the development of life-changing therapies and ensuring global access. We are seeking passionate and ambitious individuals to join our mission and make a direct impact.
Responsibilities
- Prepare and oversee the preparation of complex regulatory submissions for investigational and commercial products in assigned territories, adhering to ICH and regional requirements.
- Submit complex regulatory documents including safety reports, amendments, supplements, and license renewals for clinical trial applications and marketing authorizations.
- Prepare the Company Core Data Sheets (CCDS) for assigned products.
- Contribute to the regulatory review of draft Product Company Core Safety Information (CCSI) and ensure updates to CCDS or CCSI are implemented.
- Ensure product packaging and associated information are updated and maintained in accordance with product licenses.
- Provide strategic regulatory advice.
- Maintain up-to-date knowledge of regulatory requirements and communicate changes to project teams and senior management.
- Initiate and contribute to local and global process improvements within the Regulatory Affairs Department and other departments.
- Plan, schedule, and arrange own activities and those of direct reports.
- Act as the primary Company contact with Regulatory Authorities.
- Lead a small team in the preparation of submissions and maintenance of licenses.
- Represent Regulatory Affairs on submission teams.
Requirements
- 10+ years of experience in Regulatory Affairs or other relevant industry experience.
- Excellent verbal and written communication skills and interpersonal skills.
- In-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
- In-depth understanding of current global and regional trends in Regulatory Affairs.
- Capability to develop and implement regulatory strategy.
- Capability to manage complex negotiations with Regulatory Authorities.
- Ability to lead a small team in preparation of submissions and maintenance of licenses.
- Ability to act with no immediate direction from a senior Regulatory Affairs professional.
- Demonstrated ability to act as primary Company contact with Regulatory Authorities.
- Direct experience working with Regulatory Authorities in assigned territories is required.
- Experience representing Regulatory Affairs on submission teams is mandatory.
- Previous people management experience is desirable.
Skills
- Regulatory Affairs
- Regulatory Submissions
- ICH Requirements
- Regional Regulatory Requirements
- Company Policies and Procedures
- Safety Reports
- License Renewals
- INDs/CTAs
- NDAs/MAAs
- Company Core Data Sheets (CCDS)
- Product Company Core Safety Information (CCSI)
- Product Packaging
- Regulatory Strategy
- Process Improvement
- Communication Skills
- Interpersonal Skills
- Negotiation Skills
- Leadership
- People Management
Experience Level
- 10+ years of experience
Education Level
- Degree in a scientific field is preferred.
About the Company
- For more than 35 years, Gilead has tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer.
- We work relentlessly to develop therapies that help improve lives and ensure access to these therapies across the globe.
- We fight against the world's biggest health challenges.
- 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.
- 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 fulfill their aspirations.
- Join Gilead and help create possible, together.