Senior Manager, Global Regulatory Process and Compliance
About the role
For our client, we are seeking a Senior Manager, Global Regulatory Process and Compliance to join the team of a leader in the Pharmaceuticals & Biotech space. In this role, you will lead regulatory compliance initiatives that strengthen global governance, risk awareness, and inspection readiness across a regulated life sciences environment. You will partner closely with regulatory, quality, operations, and senior leadership stakeholders to identify gaps, assess risk, and drive practical remediation. This position will also oversee the quality of regulatory information and support continuous improvement across key compliance processes and metrics.
Responsibilities
- Lead regulatory compliance programs to strengthen global regulatory compliance health
- Conduct compliance risk assessments and recommend risk mitigation actions
- Oversee audit and inspection readiness, including readiness assessments and subject matter expert preparation
- Monitor compliance processes and identify potential risks using KPIs and metrics
- Provide oversight for regulatory information quality and data management in Veeva RIM
- Translate audit findings and compliance assessments into actionable improvement steps
- Communicate compliance risks and recommendations clearly to senior leadership
Qualifications
- Bachelor's degree in Life Sciences, Regulatory Affairs, Quality, Technology, or a related discipline; advanced degree preferred
- 7+ years of experience in Regulatory Affairs, compliance, Quality, Regulatory Operations, or a GxP function in pharma/biotech
- Experience leading compliance programs, risk assessments, audits, inspection readiness activities, and cross-functional initiatives
- Strong knowledge of FDA, EMA, MHRA, PMDA expectations, ICH guidelines, and GxP requirements
- Experience with Veeva Vault RIM or a similar Regulatory Information Management system preferred
- Ability to perform root-cause analysis and compliance risk assessments effectively
- Strong project management and stakeholder engagement skills
Benefits
- Comprehensive health insurance, including Medical, Dental, and Vision
- Retirement savings 401(k) with company contributions
- Flexible spending accounts (FSA/HSA)
- Life insurance coverage
- Paid time off and wellness programs
- Employee ownership opportunities through stock options
Location: Remote - US based candidates only, no visa sponsorship available
Compensation: $139,800 – $184,800 annually