Associate Director, Regulatory Affairs CMC

Benefits

Additional Information

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 At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As an Associate Director, CMC Regulatory Affairs for Biologics, at Gilead you will be 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. Specific Job Responsibilities: Ensure that CMC dossiers meet ICH format and content requirements, as well as the specific local requirements of individual countries. Takes a leadership position in conducting risk assessments on major global CMC regulatory issues. Must be pro-active in staying current with registration requirements in each of the applicable regions, and must communicate this information to the corporation on a timely basis. Play a leadership role on project and other teams in developing global CMC regulatory and change control policies and strategies. Work proactively to build contacts with local Health Authorities, and to present a positive image of Gilead in all discussions with Health Authorities. Responsible for ensuring timely discussion with Health Authorities regarding responses to questions, and will work with international colleagues to ensure consistency of responses to international Health Authorities. On a regular basis, participate in significant industry trade groups and regulatory professionals associations. Take a leadership role in updating the corporation on major international CMC regulatory guidance. Will be expected to use industry network to maintain an awareness of the "pulse" of CMC best practices, and to disseminate this information to the corporation. Form ad hoc task forces to address critical CMC issues on behalf of project and department teams Excellent verbal and written communication skills and interpersonal skills are required. Regulatory Strategy Facilitate good communication and transparency of CMC information to relevant functions. Provide consistent, high-quality Regulatory CMC input on CMC issues and risks along with mitigation plans/options. Lead and coordinate development of regional Regulatory CMC strategy, CMC submission content and timing to ensure alignment as outlined in the global regulatory strategy document. Ensure the Regulatory CMC strategy includes input from all geographies, commercial strategy and supports the Target Product Profile. Refine the Regulatory CMC strategy and updates as new data becomes available or as necessary. Liaise with RPT members to prepare CMC updates and/or regulatory position papers for consideration by the Research Project Review, Development Project Review and High Level Management, as necessary. Coordinate the provision of Regulatory CMC input on key milestones and stage gate recommendations, as necessary. Develop CMC lifecycle management plans with input from RPT. Health Authority Interaction Coordinate and facilitate development of regional Regu