Senior Associate, CMC Regulatory Affairs-Biologics

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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
 

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Sr. Associate, CMC Regulatory Affairs – Biologics

Gilead Sciences is seeking a knowledgeable and motivated professional capable of working effectively in a multi-disciplinary team environment. The successful candidate will assume a full-time employment role in the capacity of Senior Associate in Gilead’s Regulatory Affairs CMC department.

Job Description:

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

• Responsible for routine clinical and commercial labeling approvals and changes, protocol reviews, drug listing review and ensure ensuring product packaging and associated information is updated and maintained in accordance with the product license.

• Develop and maintain knowledge of regulatory requirements independently and with line manager.

• Assess change controls for regional regulatory impact and record assessment using a variety of internal systems.

• Contribute to local process improvements, which have an impact on the working of the RA CMC function or other departments.

• Work cross-functionally within a matrixed organization.

• Primarily plans, schedules and arranges own activities in alignment with project goals and deadlines.

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

• Must work well under deadlines and have excellent attention to detail.  Work is performed under limited direction of a senior Regulatory Affairs professional.

Minimum Qualifications:

• A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at least 6 years with a BA/BS, or at least 4 years with an MA/MS. 

• Relevant Regulatory CMC submission experience.

• Knowledge of global CMC regulatory landscape.

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

• Strong computer and organization