Senior Manager, Business Process Office, Global Regulatory Affairs (GRA)
About The Position
The Senior Manager, Global Regulatory Affairs (GRA) Business Process Office (BPO) is a key contributor who supports continuous improvement, process optimization, and operational excellence efforts across the GRA organization. This role works closely with GRA leadership, process owners, and cross-functional stakeholders to support the assessment, design, implementation, and monitoring of efficient, compliant, regulatory processes. The Senior Manager applies established continuous improvement and change management methodologies to help improve ways of working across Global Regulatory Affairs. The role supports business decision making by providing data, analysis, and practical recommendations that contribute to advancing GRA’s operational effectiveness, compliance with Regulatory requirements and internal company standards, and alignment with business priorities.
Requirements
- Bachelor’s degree in Life Sciences, Business Administration, or related field (Advanced degree preferred)
- 5+ years of experience in pharmaceutical and/or biotech industry
- 3+ years of experience in Regulatory Affairs or drug development project management
- Knowledge of Lean, Six Sigma, and continuous improvement methodologies
- Knowledge of the ways KPIs and metrics can be leveraged as tools for monitoring performance and driving continuous improvement
- Prior experience supporting regulatory operations, business process management, or continuous improvement within a regulated industry (pharmaceuticals, biotech, medical devices, or similar).
- Demonstrated experience leading complex, cross‑functional continuous improvement or process transformation initiatives.
- Demonstrated ability to collaborate effectively in cross-functional, matrixed environments.
- Familiarity with regulatory systems, compliance frameworks, and quality control
- Strong analytical, problem‑solving, communication, and stakeholder engagement skills.
Nice To Haves
- Lean Six Sigma certification (Green Belt or equivalent).
- Experience working within a Business Process Office, Center of Excellence, or PMO‑like structure.
- Familiarity with regulatory systems, data, and digital tools that support process optimization.
Responsibilities
- Supports the planning and execution of continuous improvement and process optimization activities
- Contributes to cross-functional team efforts to support successful project through effective project planning, coordination, and execution
- Supports the coordination and monitoring of Regulatory operational support provided by internal and/or external resources
- Contributes to the identification and tracking of project risks, issues, and budget considerations
- Support the execution of standardized documentation, governance artifacts, and performance measures, under the guidance of process owners and function leadership.
- Assist process owners with current-state assessments to identify inefficiencies, risks, and variability, and support the development of future‑state process improvements that are scalable and compliant.
- Provide subject matter expertise related to process design, operational execution, and regulatory excellence.
- Support learning and awareness of continuous improvement principles and methodologies among stakeholders.
- Support application of continuous improvement methodologies into day-to-day operations.
- Apply Lean, Six Sigma, and continuous improvement methodologies (e.g., DMAIC, value stream mapping, root cause analysis) to identify improvement opportunities across Regulatory processes.
- Contribute to cross‑functional process improvement initiatives, under the direction of senior function leaders.
- Help ensure initiatives have clearly defined scope, deliverables, timelines, and success metrics.
- Support change management activities to promote adoption of new or improved processes, tools, and ways of working.
- Assist process owners in defining and tracking key process performance indicators (KPIs) to monitor effectiveness, efficiency, and compliance.
- Prepare and maintain clear, data-driven reporting on improvement initiatives, risks, and progress.
- Support alignment with GRA governance models, quality standards, and regulatory expectations.
Benefits
- medical, dental, vision insurance
- a 401(k) plan and company match
- short-term and long-term disability coverage
- basic life insurance
- a tuition reimbursement program
- paid volunteer time off
- company holidays
- well-being benefits
- up to 80 hours of sick time
- up to 120 hours of paid vacation
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
