Senior Director; Head of CMC Regulatory Affairs Digital Enablement.

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 from strategy through implementation.
• Established data acumen, understanding of advanced analytics, data architecture, and data engineering, for example, standardization of data per regulatory authorities (e.g., ALCOA, DSAB)
• Knowledge of data governance principles, systems integrations, and metadata management is a plus.

Leadership & Soft Skills:

• 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.