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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
The Associate Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This position will ensure “right first time” global approvals of CMC regulatory (Biologics) submissions, and “right to operate” by maintaining the global clinical or commercial submissions. In addition, you will be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions. As a regulatory lead you will also be responsible for ensuring that global regulatory strategy is integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams.
KEY RESPONSIBILITIES:
Responsible for preparing and/or overseeing the preparation of technically complex biologics CMC regulatory submissions which require extensive interaction with departments outside of Regulatory Affairs CMC for investigational and commercial products, in line with ICH requirements, regional requirements, and scientific and company policies and procedures. Examples include supplements and license renewals to clinical trial applications and marketing authorizations, and original INDs/CTAs and BLAs/MAAs for assigned territories.
Work with the regional CMC personnel to develop a CMC submission plan in accordance with business objectives.
Lead the development of the Regulatory CMC strategy, content, and submission timelines in accordance with business objectives.
Provide strategic regulatory CMC advice to project teams for biologics submissions.
Ensure cross-regional communication and transparency in the flow of CMC information that may affect regional regulatory strategy.
Coordinate and facilitate development of regional Regulatory CMC strategy with affiliates for local meetings and interactions.
Ensure up-to-date knowledge of biologics CMC regulatory requirements and communicate relevant changes in regulatory information to project teams and senior management in a timely manner.
Initiate local process improvements and contribute to local and / or global process improvements, which may have a significant impact for the CMC Regulatory Affairs Department or other departments.
QUALIFICATIONS:
A scientific degree with directly relevant professional experience in biologics development, global CMC Regulatory Affairs, and CMC technical areas of at least 10+ years with a BA/BS or 8+ years with an MA/MS or 2+ years with a PhD/PharmD
Excellent organizational skills and ability to work on and/or oversee multiple projects with tight timelines.
Knowledge of global CMC regulatory landscape.
Application of sound and accurate judgment to make timely decisions.
Ability to demonstrate strategic acumen and collaboration.
Advanced communication and presentation skills.
Capable of leading a team in preparation of complex regulatory submissions and maintenance of licenses.
Work is performed under consultative direction towards corporate regulatory goals and objectives.
GILEAD CORE VALUES:
Integrity (Doing What’s Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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