Sr Manager, Regulatory Affairs CMC

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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 CMC Regulatory Affairs Project Manager is responsible for supporting the planning coordination and execution of CMC regulatory activities across global clinical and commercial programs. This role partners closely with Regulatory Affairs Technical Development Quality and crossfunctional CMC teams to support timely compliant and wellorganized submissions to global health authorities.

Responsibilities:

• Coordinate and track timely regulatory assessments of CMC change controls to support global filing impacts for the development of CMC filing strategies and timelines

• Support and track CMC regulatory project activities including global quality dossier preparation global dossier lifecycle submissions approval and Health Authority communications/interactions.

• Manage CMC RA product team meetings (i.e. meeting agendas meeting materials document meeting minutes discussion outcomes and follow-up on action items). Compile and monitor product portfolio including scope priorities milestones and emerging regulatory risks to product variants

• Maintain and track global CMC regulatory filing plans project timelines and metrics that support visibility alignment and execution across product variants.

• Coordinate CMC RA product team and technical content author activities to ensure highquality submission content through stakeholder engagement clear communication and timely resolution of issues.

• Track and organize CMC filing related documentation (e.g. data availability timelines validation data specifications analytical methods stability data Module 3 content).

• Support regulatory strategy development by identifying and tracking regulatory fileability risks track.

• Lead meeting logistics and documentation including agendas minutes and action item tracking and followup.

• Serve as a liaison with PDM product and portfolio Project Managers for CMC RA topics including timelines and project milestones for preparation of global regulatory submissions Health Authority briefing packages responses and meeting materials.

• Contribute to process improvements bestpractice development and regulatory CMC initiatives.

Basic Qualifications:

• Bachelors degree in Life Sciences Chemistry Pharmacy or related discipline.

• Min. 46 years of relevant experience in pharmaceutical project CMC development CMC Regulatory Affairs.

Preferred Qualifications:

• Strong project management skills with a track record of managing complex projects and meeting challenging deadlines. Prior experience in regulatory and CMC project management preferred.

• Excellent organizational time management and problem-solving skills.

• Excellent communication and interpersonal skills.

• High attention to detail and strong ability to think critically.

• Proven experience with project management tools (i.e. Microsoft Office Suite Smartsheet Visio Thinkcell Microsoft Project).

• Ability to work collaboratively in a fast-paced dynamic environment.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

For jobs in the United States:

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

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