Sr Manager, Regulatory Affairs

职位描述

Company Overview

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 Responsibilities:

• Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.

• Responsible for submitting moderately complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs for assigned territories.

• Responsible for preparation of the Company Core Data Sheets (CCDS) for assigned products and ensures that any updates to the CCDS and the Product Company Core Safety Information (CCSI) are implemented.

• Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license.

• Acts as project team representative for specified products depending on complexity of the project.

• May provide strategic regulatory advice as appropriate.

• Maintains knowledge of regulatory requirements up to date and communicates changes in regulatory information to project teams and senior management in a timely manner.

• May contribute to training of staff under direction of Senior Regulatory Affairs Professional.

• May initiate local process improvements and contribute to local and / or global process improvements, which have a moderate impact on the Regulatory Affairs function or other departments.

• Plans, schedules, and arranges own activities and may direct others in accomplishing objectives.

Minimum Education and Basic Qualifications:

• Bachelor’s Degree and 8 years of experience

OR

• Master’s Degree and 6 years of experience

OR

• PhD

Preferred Qualifications:

• Excellent organization skills and ability to work on a number of projects with tight timelines is required.

• Excellent verbal and written communication skills and interpersonal skills are required.

• Must be knowledgeable of regulatory requirements, including ICH requirements and regional requirements for assigned territories.

• Must be capable of developing and implementing regulatory strategy and of managing negotiations with Regulatory Authorities.

• May take a leadership role in updating and preparing the Company for minor changes in legislation in assigned territories.

• Must be capable of leading a small team in preparation of submissions.

• Work is performed under limited direction of a senior Regulatory Affairs professional. Is recognized as a knowledgeable resource for Regulatory Advice on specific topics in other departments

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.