Vp Regulatory Innovation

Description:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to Create Possible and improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include Oncology, Inflammatory Diseases, and Virology.

Since its founding in Foster City, California, in 1987, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, an impressive pipeline of investigational drugs across therapeutic areas, and over 14,000 employees in offices across six continents. We are revolutionizing healthcare by bringing urgently needed medicines to patients with HIV/AIDS, liver diseases, hematology and oncology, inflammation and respiratory diseases, and cardiovascular conditions. Our portfolio of more than 25 marketed products includes an antibody-drug conjugate for the treatment of certain patients with unresectable locally advanced or metastatic triple-negative breast or locally advanced or metastatic urothelial cancers, two CAR T therapies approved for the treatment of adult patients with certain B cell lymphomas or Mantle Cell Lymphoma, and innovative complete treatment regimens for HIV and chronic hepatitis C infection available in once-daily single pills.

Millions of people around the world are living healthier lives because of innovative therapies developed by Gilead. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors working together and supporting each other to help make a real difference to the lives of patients.

Reporting to the SVP of Regulatory Affairs and Development Sustainability, the VP of Regulatory Innovation, Content and Operations will lead our organization's digital transformation and systems innovation across the end-to-end regulatory lifecycle from early development through post-marketing activities. This role is crucial in maintaining and improving our ability to efficiently deliver high-quality submissions to health authorities around the world. The ideal candidate should have an in-depth knowledge of regulatory operations, expertise in content management and delivery, plus enthusiasm for digital innovation, and a history of successfully leading change initiatives with both internal and external partners. (The primary location for this role is Foster City with possible locations in Parsippany, NJ and Cambridge, UK.)

The VP will be a member of the Regulatory Affairs Leadership Team and as such will contribute to defining and executing the regulatory vision, roadmaps, initiatives and outcomes of the organization.

Key Responsibilities: 

General 

Provide leadership and management of the Regulatory Innovation, Content (i.e., Medical Writing and Strategic Labeling teams) and Operations Team.
Recruit, retain, develop, motivate and coach talent, fostering professional growth and ensuring a strong succession pipeline.
Create a culture of collaboration, excellence and innovation which inspires team members to be trailblazers and perform at their highest abilities optimizing their effectiveness to enable the timely and quality of global and local affiliate submissions.
Develop and manage budgets effectively to achieve RA team and Gilead business goals.
Oversee the efficient utilization of both internal and vendor staff to ensure the timely and high-quality development and submission of regulatory applications worldwide.
Lead and direct the team in developing and implementing appropriate processes, procedures to create effective system workflows to produce an efficient, smooth-running submission assembly line.
Develop systems and policies that ensure the accuracy and accessibility of regulatory information and content globally.
Ensure all processes and submissions adhere to local and international regulatory guidelines, laws, and standards.
Build, maintain and advance partnerships with key stakeholders across Regulatory Affairs, Clinical Development, PDM, CMC Regulatory, Quality Assurance, Commercial functions, Information Technology and Development Systems to advance near-term regulatory priorities and long-term innovation efforts with broader enterprise level objectives.
Drive change management initiatives to ensure the successful adoption of digital tools and processes across the organization.
Define key performance indicators (KPIs) and metrics to measure the success and impact of ongoing activities and innovation efforts, regularly reporting progress to leadership.
Focus on providing insights into the operations and performance of functional areas and service providers across the organization to ensure streamlined end-to-end content and application preparation for submissions and post-marketing content management. 

Digital Transformation

Lead the organization toward a more digital-enabled future by identifying, evaluating, and implementing innovative technologies and solutions that enhance regulatory operations efficiency and effectiveness.
Develop, update and execute a strategic digital roadmap for automating and streamlining regulatory submissions to health authorities worldwide, optimizing processes as appropriate, from data collection to submission.
Work closely with CROs, industry bodies (e.g., Transcelerate) and other external partners to develop standards and innovative solutions for gathering data / information / content, ensuring seamless data exchange and compliance with regulatory requirements.
Evaluate and select technology vendors and partners to support innovation initiatives, ensuring solutions meet regulatory requirements and industry best practices.
Represent Regulatory Affairs at the highest internal technology review committees and provide guidance and direction with impact to ensure the preparation of robust technology business cases.
Stay current with regulatory trends, changes, and requirements related to digital submissions, search out new opportunities to support improved regulatory operations, content management and incorporate this knowledge into strategic planning.

Qualifications:

Bachelor's degree in a relevant field; advanced degree (e.g., MBA, PhD) preferred.
Proven leadership experience (15+ years) and skills, with the ability to inspire and mentor a diverse and global team.
Extensive experience in regulatory operations within the pharmaceutical or biotechnology industry, with a strong emphasis on digital transformation and automation.
Proven track record of successfully leading and implementing digital innovation projects in a regulated environment.
Broad experience with industry regulatory systems and standards such as eCTD, eTMF (Electronic Trial Master File), and RIM (Regulatory Information Management) vault systems.
Experience in selecting, implementing, and optimizing eTMF and RIM vault systems for efficient data management and regulatory compliance.
Exceptional communication and stakeholder management abilities.
Strong interpersonal skills that facilitate collaboration across functions to identify business solutions on regulatory issues.
In-depth knowledge of global regulatory requirements and submission processes.
Extensive knowledge of regulatory requirements, including ICH requirements and regional requirements and understand current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business.
Proven capability for leading transformational activities to prepare the Company for major changes in legislation which impact across departments.