Senior Manager, Global Regulatory Process and Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee regulatory compliance initiatives that enhance GRA’s compliance health, readiness for inspections, management of regulatory information, and proactive management of regulatory risks.

• Evaluate compliance risks and trends independently, formulate risk-based recommendations, and spearhead cross-functional projects through implementation and effectiveness assessment.

• Collaborate with Global Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC, Regulatory Operations, and Regulatory Technology.

• Ensure oversight of Veeva RIM data stewardship and the quality of regulatory information.

• Supervise data quality and address systemic issues related to information and processes.

• Prepare GRA for audits and health authority inspections, including conducting readiness assessments, preparing subject matter experts, providing support during audits/inspections, performing post-audit assessments, analyzing trends, and overseeing remediation efforts.

• Conduct compliance risk assessments for GRA and maintain the compliance risk portfolio.

• Evaluate the impact of regulatory changes, health authority expectations, audit/inspection results, and internal compliance concerns on GRA.

• Offer compliance guidance and challenge practices that may pose regulatory or inspection-readiness risks.

• Monitor essential GRA processes, set KPIs, thresholds, and escalation triggers, investigate recurring problems, and propose corrective actions.

• Collaborate with Business Process Owners and subject matter experts to implement actions, assign responsibilities, monitor completion, and verify effectiveness.

• Create compliance KPIs, risk indicators, dashboards, escalation thresholds, and management reports.

• Integrate compliance data to pinpoint recurring and emerging risks and report compliance health, risks, actions, owners, and status to GRA leadership and the Regulatory Compliance Network.

• Lead root-cause analysis and problem-solving for significant or persistent compliance challenges.

• Develop practical guidance, tools, training materials, and lessons learned.

• Incorporate compliance requirements into daily processes and reinforce business accountability.

• Operate independently, lead cross-functional initiatives, hold action owners accountable, and communicate risks and recommendations to senior leadership.

• May supervise direct reports or contractors, providing mentorship, coaching, and guidance.

⛳️ Requirements

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

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

• Proven experience in independently leading compliance programs, conducting risk assessments, preparing for audits/inspections, and implementing remediation and cross-functional improvement initiatives.

• Strong understanding 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 capability to conduct root-cause analysis, compliance risk assessments, trend analyses, and effectiveness monitoring.

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

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

• Strong analytical and problem-solving skills with a proven ability to convert data into actionable compliance recommendations.

• Excellent project/program leadership, stakeholder management, facilitation, and organizational change skills.

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

• Proficiency with regulatory information management systems such as Veeva RIM and electronic document management systems.

• Familiarity with compliance monitoring dashboards, data analytics, and reporting tools such as Power BI, Tableau, or equivalent.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint, Outlook, Teams).

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

• Travel: Less than 15%.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Option to participate voluntarily in the Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• Flexible Spending Account/Health Savings Account.

• Life insurance.

• Paid Time Off.

• Wellness programs.