Sr Director, Regulatory Affairs CMC

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
 

Responsibilities

1. Strategy and Roadmap Development

• Define and continuously refine a CMC RA Digital Enablement roadmap aligned to organizational priorities and enterprise platforms.
• Prioritize use cases across submission acceleration, regulatory intelligence, authoring automation, and knowledge reuse.
• Translate CMC-specific digital needs into business cases for enterprise-level investments.
• Lead the business case development and ROI analysis for new digital investments, effectively communicating trade-offs between speed, cost, and scope to leadership.

2. Program Delivery and Vendor Coordination

• In partnership with IT, identify, evaluate, and create strategic partnerships with established and emerging technology providers to bring cutting-edge solutions and expertise into the organization
• In partnership with key stakeholders, drive digital pilots and implementations (e.g., SCMS, NLP-based HAQ clustering, automated impact assessments).
• Foster relationships with internal partners (e.g., IT, Technical Development) and external vendors (e.g., AI/NLP platforms, system integrators).
• Define and track key performance indicators (KPIs) and objectives and key results (OKRs) for all digital initiatives, linking them directly to business outcomes such as submission cycle time reduction, improved inspection-readiness, or enhanced data reuse.

3. Innovation, Change Leadership, and Continuous Improvement

• Articulate a compelling vision for digital transformation within CMC RA.
• Scan the digital landscape for emerging tools applicable to CMC RA.
• Lead change management, including upskilling, communication planning, and user adoption.
• Partner with Continuous Improvement team to identify areas where digital can remove friction or enable leapfrog innovation.
• Foster a culture of continuous innovation and improvement across CMC RA.

4. Collaboration and Influence

• Serve as a bridge between CMC RA and PDM digital governance groups.
• Represent CMC RA in enterprise-wide digital steering committees and structured content working groups.
• Align efforts with data governance, structured data initiatives, and broader RA digital programs.

Qualifications:

Education & Experience:

• Bachelor’s degree in a scientific or technical discipline required (advanced degree preferred) – with biopharma and/or regulatory affairs experience of 14+ years with a BA/BS or 12+ years with an advanced degree.
• Five or more years of experience in digital or innovation roles preferred.
• Strong understanding of CMC regulatory submissions and the structure/content of Module 3.
• [Preferred]: Certifications in product ownership (e.g., CSPO), business relationship management (e.g., CBRM), or agile methodologies (e.g., SAFe) are a plus.

Technical & Strategic Skills:

• Demonstrated enterprise mindset with ability to align CMC RA needs to enterprise platforms and solutions, ensuring scalability, interoperability, and long-term business value.
• Demonstrated 'product management' mindset with experience defining product vision, managing backlogs, and translating customer (i.e., scientist/author) needs into features and roadmaps.
• Experience with Veeva Vault RIM, SCMS, Cloud-based Submission Solutions, or equivalent RIM/structured content systems.
• Expertise in AI/ML/NLP use cases (e.g., Robotic Process Automation) in life sciences, especially for content authoring or regulatory intelligence.
• Proven success leading digital initiatives fr