Senior Regulatory Specialist
About the role
Job Title: Senior Regulatory / GMP Subject Matter Expert (Laboratory Operations)
Position Summary:
We are seeking an experienced Senior Regulatory / GMP Subject Matter Expert (SME) to support laboratory quality and compliance initiatives within a regulated pharmaceutical, biotechnology, or life sciences environment. The ideal candidate will possess extensive knowledge of GMP regulations, laboratory quality systems, regulatory expectations, and remediation programs. This role will be responsible for assessing current laboratory practices, identifying compliance gaps, developing corrective action strategies, and overseeing implementation activities to ensure regulatory readiness and operational excellence.
Required Qualifications:
Bachelor's or Master's degree in Life Sciences, Chemistry, Microbiology, Pharmaceutical Sciences, Engineering, or a related discipline. 10+ years of experience in GMP-regulated pharmaceutical, biotechnology, or medical device environments. Extensive knowledge of QC laboratory operations, GMP regulations, CAPA systems, and quality management systems. Proven experience conducting regulatory compliance assessments and remediation projects. Strong understanding of FDA 21 CFR Parts 210, 211, 11, ICH guidelines, and global GMP requirements. Experience supporting regulatory inspections and audit readiness activities. Excellent analytical, problem-solving, communication, and stakeholder management skills.
Preferred Qualifications:
Previous experience serving as a GMP Compliance Consultant or Regulatory SME. Experience leading large-scale laboratory remediation and quality transformation projects. Certification in Quality, Regulatory Affairs, or GMP-related disciplines is a plus.
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Senior Regulatory Specialist
About the role
Job Title: Senior Regulatory / GMP Subject Matter Expert (Laboratory Operations)
Position Summary:
We are seeking an experienced Senior Regulatory / GMP Subject Matter Expert (SME) to support laboratory quality and compliance initiatives within a regulated pharmaceutical, biotechnology, or life sciences environment. The ideal candidate will possess extensive knowledge of GMP regulations, laboratory quality systems, regulatory expectations, and remediation programs. This role will be responsible for assessing current laboratory practices, identifying compliance gaps, developing corrective action strategies, and overseeing implementation activities to ensure regulatory readiness and operational excellence.
Required Qualifications:
Bachelor's or Master's degree in Life Sciences, Chemistry, Microbiology, Pharmaceutical Sciences, Engineering, or a related discipline. 10+ years of experience in GMP-regulated pharmaceutical, biotechnology, or medical device environments. Extensive knowledge of QC laboratory operations, GMP regulations, CAPA systems, and quality management systems. Proven experience conducting regulatory compliance assessments and remediation projects. Strong understanding of FDA 21 CFR Parts 210, 211, 11, ICH guidelines, and global GMP requirements. Experience supporting regulatory inspections and audit readiness activities. Excellent analytical, problem-solving, communication, and stakeholder management skills.
Preferred Qualifications:
Previous experience serving as a GMP Compliance Consultant or Regulatory SME. Experience leading large-scale laboratory remediation and quality transformation projects. Certification in Quality, Regulatory Affairs, or GMP-related disciplines is a plus.