Senior Manager - Global Regulatory Process and Compliance

General Description:
The Senior Manager, Global Regulatory Compliance & Inspection Readiness is responsible for leading regulatory compliance programs that strengthen GRA’s compliance health, inspection readiness, regulatory information management, and proactive management of regulatory risk.

The role independently assesses compliance risks and trends, develops risk-based recommendations, and leads cross-functional initiatives through implementation and effectiveness monitoring. The Senior Manager partners across Global Regulatory Affairs and with Quality, Safety/Pharmacovigilance, Clinical, CMC, Regulatory Operations, and Regulatory Technology to ensure regulatory processes, information, and supporting systems remain compliant, inspection-ready, and aligned with global health authority expectations.

The role provides oversight of Veeva RIM data stewardship and regulatory information quality, partnering with Data Management, Business Process Owners, and Data Owners/Stewards to strengthen data standards, business rules, ownership, and accountability. This includes monitoring data quality and identifying and driving resolution of systemic information and process risks.

The Senior Manager also serves as a key GRA partner for audits and inspections where Regulatory Affairs is host or in scope, leading readiness assessments, SME preparation, audit/inspection support, post-audit assessments, trend analysis, remediation oversight, and integration of lessons learned into the GRA compliance program.
 

Regulatory Compliance & Risk Management

• Conduct GRA compliance risk assessments, determine regulatory and business impact, and recommend actions to address identified risks. 

• Maintain the GRA compliance risk portfolio, including mitigation actions, owners, timelines, escalation, and effectiveness checks. 

• Assess regulatory changes, health authority expectations, audit/inspection outcomes, and internal compliance issues to determine impacts to GRA. 

• Determine whether identified issues require Quality-system action, management escalation, or process improvement and drive the appropriate response. 

• Provide compliance guidance and appropriately challenge practices that create regulatory or inspection-readiness risk.
  

Audit & Inspection Readiness

• Lead GRA preparation for audits and health authority inspections where Regulatory Affairs is host or in scope. 

• Conduct readiness assessments, identify gaps, and coordinate actions needed before an audit or inspection. 

• Prepare GRA SMEs through storyboards, document review, mock interviews, and inspection-readiness coaching. 

• Coordinate GRA participation in GCP, GVP, and other GxP audits and inspections with Quality and the audit/inspection host. 

• Conduct post-audit and inspection reviews to identify GRA-specific findings, recurring themes, and broader compliance risks. 

• Track GRA remediation actions through completion and confirm that actions address the identified risk.
  

Compliance Programs & Process Health

• Monitor critical GRA processes, including health authority questions, regulatory commitments, submissions, and regulatory information, against defined compliance requirements. 

• Establish KPIs, thresholds, and escalation triggers to identify process failures and compliance risks early. 

• Investigate recurring issues and adverse trends, determine root cause, and recommend corrective action or process improvement. 

• Work with Business Process Owners and SMEs to implement actions, assign ownership, track completion, and confirm effectiveness.

Regulatory Information, Data Management & Stewardship

• Provide compliance oversight of regulatory information in Veeva RIM to support data quality, completeness, timeliness, traceability, and inspection readiness. 

• Lead Veeva RIM data stewardship activities, including monitoring data quality, identifying trends and recurring issues, coordinating remediation, and escalating systemic risks. 

• Partner with Data Management, Regulatory Operations, Business Process Owners, and Data Owners/Stewards to establish and maintain data standards, business rules, ownership, and accountability. 

• Monitor Veeva RIM data quality metrics and use trends to identify root causes and drive corrective actions or process improvements. 

• Assess Veeva RIM changes and enhancements for data and compliance impact and ensure appropriate business requirements and controls are addressed.

Compliance Analytics & Management Reporting

• Develop and monitor GRA compliance KPIs, risk indicators, dashboards, and escalation thresholds. 

• Combine audit, inspection, quality, process, commitment, and regulatory information data to identify recurring and emerging compliance risks. 

• Provide GRA leadership and the Regulatory Compliance Network with clear reporting on compliance health, key risks, actions, owners, and status. 

• Use compliance data to determine whether corrective actions and improvements are working and where additional action is needed

Continuous Improvement & Compliance Culture

• Turn audit findings, inspection lessons, compliance assessments, and monitoring results into prioritized improvement actions. 

• Lead root-cause analysis and problem-solving for significant or recurring compliance issues. 

• Develop practical guidance, tools, training, and lessons learned based on identified compliance needs. 

• Work with GRA teams and Business Process Owners to build compliance requirements into day-to-day processes and reinforce business ownership of compliance. 

Leadership Expectations

• Work independently to identify, assess, and drive compliance issues to resolution. 

• Bring forward a recommended solution—not just the problem—when escalating issues. 

• Apply sound judgment to determine risk, priority, escalation, and the appropriate course of action. 

• Lead cross-functional initiatives from problem identification through implementation and effectiveness monitoring. 

• Hold action owners accountable for agreed deliverables and timelines and escalate when needed. 

• Appropriately challenge decisions or practices that create compliance risk. 

• Communicate risks, recommendations, and decisions clearly to senior leadership. 

• Coach team members and lead employees, contractors, or project teams as assigned.
   

Supervisory Responsibilities:  

• May manage direct reports or contractors depending on business needs.

• Provides mentorship, coaching, and guidance to team members supporting compliance programs.

• Collaborates closely with cross-functional peers to ensure successful execution of regulatory compliance initiatives.

Computer Skills:  

• Proficiency with regulatory information management systems (e.g., Veeva RIM) and electronic document management systems.

• Experience with compliance monitoring dashboards, data analytics, and reporting tools (Power BI, Tableau, or equivalent).

• Proficiency with Microsoft Office Suite (Word, Excel, Power Point, SharePoint, Outlook, Teams).
  

Other Qualifications:

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality, Technology, or related discipline; advanced degree preferred.

• 7+ years of progressive experience in Regulatory Affairs, regulatory compliance, Quality, Regulatory Operations, or another GxP function within the pharmaceutical/biotechnology industry.

• Demonstrated experience independently leading compliance programs, risk assessments, audits/inspection readiness activities, remediation, and cross-functional improvement initiatives.

• Strong working knowledge of FDA, EMA, MHRA, PMDA and other global health authority expectations, ICH guidelines, applicable GxP requirements, 21 CFR Part 11, and ALCOA+ data integrity principles.

• Experience supporting or leading health authority inspections and internal audits.

• Demonstrated ability to perform root-cause analysis, compliance risk assessment, trend analysis, and effectiveness monitoring.

• Experience with Veeva Vault RIM/BRIM or comparable Regulatory Information Management platforms strongly preferred.

• Experience developing compliance KPIs, dashboards, trend analyses, and executive-level reporting.

• Strong analytical and problem-solving capabilities with demonstrated ability to translate data into actionable compliance recommendations.

• Strong project/program leadership, stakeholder management, facilitation, and organizational change capabilities.

• Ability to work independently, manage competing priorities, and exercise sound judgment in a complex global environment.

• RAC, ASQ CQA, Six Sigma/Lean, project management, or comparable certification preferred.

Travel: < 15%