Senior Regulatory Compliance Specialist, Clinical Operations
1 week ago
Larimar Therapeutics Inc., a clinical-stage biotechnology company, seeks an experienced Senior Regulatory Compliance Specialist to join its Clinical Operations team. This role will provide critical support in ensuring compliance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulations.
Responsibilities- Develop and execute risk-based audit strategies for Clinical and Pharmacovigilance programs.
- Oversee the execution of external audits of GCP/GVP vendors and investigator sites, as well as internal GCP/GVP audits.
- Collaborate with Quality representatives at Contract Research Organizations (CROs) and service providers to ensure quality agreements and study plans are developed and implemented.
- Participate in relevant clinical and safety-related team meetings.
- Support the development and/or revision of Quality, Clinical, and Pharmacovigilance processes and procedures, including SOPs and risk assessment tools.
A Bachelor's degree in life sciences is required, along with a minimum of 8+ years of experience in a Quality role supporting Clinical Operations and/or Pharmacovigilance departments within a biotechnology or pharmaceutical environment.
The ideal candidate will possess thorough knowledge of GxP systems, quality principles, and GCP/GVP regulations, as well as experience hosting GCP regulatory inspections.
BenefitsLarimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan, including 401K, and a flexible PTO policy.
Estimated salary: $140,000 - $170,000 per year.
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