Associate Director, Regulatory Submission Management

Job description

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. Regulatory Submission Management (RSM) acts as a partner for strategic planning and execution of the portfolio, to ensure global Regulatory submissions are scalable, seamless, and optimized. We are a trusted companion across Regulatory Affairs, bridging strategy and execution while building knowledge across the portfolio to bring therapies to patients faster, together. As an Associate Director, RSM, you will have a primary focus on regulatory portfolio planning across multiple programs and assigned submissions of increasing complexity. Portfolio planning and submission assignment include, but are not limited to, developing global filing plans, planning and executing original marketing applications across multiple regions, and partnering with the Global Regulatory Lead in aligning the regulatory strategy within the regulatory project teams. You will be responsible for partnering with RA Liaisons and GRAD (Global Regulatory Affiliates and Distributors) in regulatory submissions portfolio planning and oversee the submission execution of the full submission lifecycle as a functional area expert. You will oversee timelines, communications, meetings, and other interactions to ensure submission deliverables are met on time and meet technical specifications per health authority requirements. You will be the Regulatory Submission Management representative within the Submission Team to various partners and stakeholders. You will typically manage multiple major submissions simultaneously. You will also contribute to short- and long-range RSM strategies, plans and infrastructure development. You will lead RSM process improvement activities and lead complex Regulatory initiatives and/or complex Development initiatives. This role does not include responsibilities for regulatory strategy which are led by RA Liaisons and GRAD. This role is based out of Foster City CA and does not provide relocation. Essential Duties and Job Functions: Directs planning and execution of regulatory programs and submission activities for highly complex global submissions and/or initiatives. Partner with RA Liaisons and GRAD to generate a global filing plan highlighting and overlaying each region’s Regulatory submission pathways through approval. This includes the preparation and maintenance of program level timelines with regulatory milestones. May lead the Regulatory Portfolio Planning for programs or submissions on an as needed basis. Directs moderately complex project/initiative communications and ensures that all stakeholders are fully informed and knowledgeable of project activities and their status. Plans and conducts regulatory submission team meetings. Anticipates obstacles and develop solutions within the team. Fosters effective and productive communication among various Regulatory Affairs groups including RA Liaisons, GRAD, Labeling, Advertising and Promotion, Innovation, Digital & External Partnerships (IDEP), Medical Writing, and representatives from other functional areas, such as Regulatory CMC, as appropriate, via proactive networking and facilitation of the Regulatory Project Team. Provides Regulatory Submission Management support for programs, projects, or initiatives; attends sub-team meetings; organizes ad hoc working groups as needed. May develop and implement continuous improvement, innovation and optimization initiatives across the department. Manages 2 – 4 major regulatory submissions including but not limited to NDAs, MAAs, BLAs, sNDAs/T2Vs, INDs, RtQs, submissions across projects/programs (platform). May partner with RA Liaisons and/or GRAD to support the portfolio planning for a specific program, lead a sub-capability within RSM or lead submission execution for a specific region within the RSM organization. In relation to regulatory submissions, coordinates, tracks and prepares project information and activities, including minutes, timelines, action items and function-specific deliverables. Ensures integration of project timing, scope and resources. Ensures timely, efficient and effective meetings and progress on activities between meetings. Will initiate or contribute to local and global process improvements across therapeutic areas which have a significant impact on the business and work collaboratively with other functional areas and Regulatory Affairs’ functions at other global sites. Organizes and/or leads preparation of high-quality documents for review by internal committees and external stakeholders. May author documents and/or procedures for leadership teams. Acts as a subject area expert for specific project, processes and/or regions. Ensures that work complies with established practices, policies and processes and technical specifications in accordance with global health authority requirements. Works with RA Liaison and/or GRAD to ensure that submissions are prepared in line with ICH requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures. Basic Qualifications: 10+ Years with BS/BA OR 8+ Years with MS/MA or MBA Preferred Qualifications: BA/ BS with 10+ relevant submission management, regulatory project management or regulatory operations experience in the biopharma industry; or 8+ years’ relevant experience with MA/MS/MBA; or 5+ years’ relevant experience with PharmD/PhD Proven effectiveness managing submission teams in life sciences, including effectiveness in preparing compelling documentation for senior leadership, determining the appropriate scope of projects, helping teams develop creative alternative scenarios, and acting effectively as a thought partner to others. Proven track record of successfully managing multiple submissions simultaneously Knowledgeable in drugs and biologics development and regulatory requirements Mentorship or experience leading others in a matrixed environment strongly preferred. PMP (Project Management Professional) or other PM certification or equivalent is a plus. Recognized as a functional area expert for specific systems, products, programs, projects and/or initiatives. Knowledge of regulatory submission requirements specific to key regions such as the US and EU and general awareness of global health authority requirements and the impact on building efficient global reuse strategies. Awareness of current global