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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Operations and Regulatory Affairs, with a strong focus on regulatory content management, digital transformation initiatives, and cross-functional collaboration. Proficient in managing global submission lifecycle and implementing operational processes that enhance compliance and efficiency.
Highest-signal resume keywords
Regulatory Operations ExperienceRegulatory Content ManagementDigital Transformation InitiativesGlobal Submission Lifecycle ManagementCross-Functional Collaboration Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory AffairsContent ManagementOperational Process DesignWorkflow ImprovementSystem Release ManagementMetadata ManagementData Governance PrinciplesAI StrategiesDigital EnablementAnalytical Problem-Solving
Soft Skills
Strong Communication SkillsPresentation SkillsStakeholder ManagementStrategic ThinkingChange Management Capability
Tools & Technologies
Veeva VaultLorenz docuBridgeAppianMicrosoft Power BIDigital Regulatory Platforms
Industry Keywords
Life SciencesPharmaceutical OperationsRegulatory ComplianceContent Lifecycle ManagementOperational Excellence
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Support long-term Regulatory Operations strategy aligned with enterprise Regulatory Affairs and CMC objectives
- Define governance models, operating standards, and business processes supporting consistency, compliance, scalability, and operational excellence
- Contribute to initiatives improving regulatory effectiveness, submission execution, and operational complexity
- Identify opportunities to leverage automation, AI, structured content, and digital technologies
- Support strategic planning, business case development, and executive-level communication
- Support enterprise regulatory content management strategy across Regulatory CMC
- Contribute to governance for content lifecycle management, structured authoring, content reuse, metadata, taxonomy, and document standards
- Improve document quality, consistency, reuse, and inspection readiness
- Partner with Regulatory authors and functional SMEs to optimize authoring processes
- Support implementation and optimization of RIM, document management systems, and content management platforms
- Support CMC regulatory activities, submissions, lifecycle management, and global regulatory coordination
- Partner with CMC Regulatory Affairs and technical teams on product development, manufacturing changes, and post-approval activities
- Contribute to roadmaps, governance, and cross-functional alignment
- Support technical and business release activities, readiness, testing, training, and continuity of execution
- Identify risks, clarify gaps, and coordinate communications
- Lead or support governance meetings, strategic discussions, operational reviews, and executive presentations
- Mentor and coach Regulatory CMC staff as needed
- Support implementation and adoption of digital regulatory platforms, AI-enabled tools, automation, and operational technologies
- Evaluate emerging technologies and assess business applicability
- Establish digital governance, standards, and best practices
- Collaborate with IT, stakeholders, and vendors on system requirements and future-state operating models
- Support enterprise automation and process modernization initiatives
- Support KPI strategy, performance measurement frameworks, dashboards, insights, reporting standards, and data quality
Requirements
What you’ll need- Bachelor’s degree required in Life Sciences, Regulatory Affairs, Information Systems, or related field; advanced degree preferred
- Experience in Regulatory Operations, Regulatory Affairs, or pharmaceutical operations
- Deep expertise in regulatory content management
- Experience supporting digital transformation initiatives and regulatory system implementations
- Ability to work across complex cross-functional organizations and multiple modalities
- Strong communication, presentation, and stakeholder management skills
- System release management and impact assessment
- Understanding of end-to-end business processes and upstream/downstream impacts of system changes
- Ability to support multiple release cycles simultaneously and manage competing priorities
- Global submission lifecycle management
- CMC Regulatory Operations experience
- Knowledge of metadata management and data governance principles
- Operational process design and workflow improvement
- AI and digital enablement strategies
- Experience with regulatory, content management, and structured data platforms
- Hands-on experience with Veeva Vault (RIM and QMS), Lorenz docuBridge, Appian, and Microsoft Power BI
- Strategic thinking and business acumen
- Executive presence and influence
- Cross-functional collaboration skills
- Change management capability
- Innovation and continuous improvement mindset
- Strong analytical and problem-solving capability
- No visa sponsorship
- Valid driving license not required
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Hybrid work arrangement
- Relocation not provided
- 10% travel requirement