Gilead Sciences, Inc. is seeking a Sr Director, Regulatory Affairs CMC to lead the digital transformation strategy and implementation for Regulatory Affairs Chemistry, Manufacturing, and Controls. You will define the CMC RA Digital Enablement roadmap, drive digital pilots, and foster a culture of innovation and continuous improvement.

What You'll Do

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 business case development and ROI analysis for new digital investments, communicating trade-offs to leadership.
Identify, evaluate, and create strategic partnerships with technology providers in partnership with IT.
Drive digital pilots and implementations (e.g., SCMS, NLP-based HAQ clustering, automated impact assessments).
Foster relationships with internal partners (IT, Technical Development) and external vendors.
Define and track KPIs and OKRs for digital initiatives, linking them to business outcomes.
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 innovation.
Foster a culture of continuous innovation and improvement across CMC RA.
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.

What We're Looking For

Bachelor’s degree in a scientific or technical discipline.
14+ years of biopharma and/or regulatory affairs experience with a BA/BS, or 12+ years with an advanced degree.
Strong understanding of CMC regulatory submissions and the structure/content of Module 3.
Demonstrated enterprise mindset with ability to align CMC RA needs to enterprise platforms and solutions.
Demonstrated 'product management' mindset with experience defining product vision and managing backlogs.
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.
Proven success leading digital initiatives from strategy through implementation.
Established data acumen, understanding of advanced analytics, data architecture, and data engineering.
Strong strategic thinking and business case development skills.
Excellent communication and stakeholder engagement abilities.
Change agent with the ability to inspire adoption and build digital fluency across teams.

Nice to Have

Advanced degree.
Five or more years of experience in digital or innovation roles.
Certifications in product ownership (e.g., CSPO), business relationship management (e.g., CBRM), or agile methodologies (e.g., SAFe).
Knowledge of data governance principles, systems integrations, and metadata management.

Technical Stack

Veeva Vault RIM
SCMS
Cloud-based Submission Solutions
AI/ML/NLP platforms
Robotic Process Automation (RPA)

Team & Environment

Partners with IT, Technical Development, Continuous Improvement team, and PDM digital governance groups.

Benefits & Compensation

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Salary range: $243,100.00 - $314,600.00

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics.