Assoc Director, Regulatory Affairs CMC

Job Description

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.

Position Overview

• May serve as a Core member of the cross-functional PDM Project Team (region specific).
• Regional Regulatory Lead on Regulatory Project Teams.
• Regional Lead and may lead cross-functional /cross- regional Regulatory Submission Teams.
• Participates on other Subteams, as applicable.
• Serves as contact with local Regulatory Authorities.
• Some positions at this grade level may partially or wholly include oversight of computerized systems.

Job Responsibilities

• Responsible for preparing and/or overseeing the preparation of technically complex regulatory CMC 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 CTNs for assigned territories.
• Provides strategic regulatory CMC advice as appropriate.
• Oversees preparation and maintenance of country specific labeling and product packaging (region specific).
• Coordinate and facilitate development of regional Regulatory CMC strategy with affiliates for local meetings and interactions.
• Ensures up-to-date knowledge of regulatory CMC. requirements and communicates relevant changes in regulatory information to project teams and senior management in a timely manner.
• Initiates local process improvements and contributes to local and / or global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or other departments.
• Plans, schedules and arranges own activities and those of direct reports (if applicable).

KNOWLEDGE & SKILLS

• Excellent organizational skills and ability to work on and/or oversee a number of projects with tight timelines.
• Excellent verbal and written communication skills and interpersonal skills.
• In-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs CMC.
• Capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
• Capable of assuming leadership role in updating and preparing the Company for minor changes in legislation in assigned territories and of actively participating in a broader cross functional team for implementation of major changes (region specific).
• 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.
• Is recognized as a knowledgeable resource for CMC Regulatory Advice in other departments.

EDUCATION & EXPERIENCE

• 10+ years of experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree.
• Degree in a scientific field is preferred.