Regulatory Intelligence
hace 13 días
Slough
We are looking for an experienced Regulatory Intelligence professional to act as the Regulatory Intelligence (RIN) lead for GCSO. This is a highly visible, cross-functional role responsible for coordinating regulatory intelligence activities, ensuring regulatory and country requirements are identified, assessed, and embedded into GCSO processes and controlled documents. This role is ideal for someone who enjoys regulatory surveillance, impact assessment, stakeholder coordination, and audit-facing activities, rather than hands-on authoring or auditing. Key Responsibilities Regulatory Intelligence & RIN Coordination • Act as the RIN Coordinator for GCSO, owning regulatory intelligence activities and workflows., • Monitor, review, and interpret global and country-specific regulations and regulatory guidance relevant to GCSO., • Assess regulatory topics and assign the appropriate GCSO SMEs based on subject matter., • Coordinate with SMEs to ensure regulatory impacts are addressed in controlled documents (SOPs, guidance, procedures)., • Serve as a central point of contact to confirm that CROs have assessed applicable regulations and understand impacts on their SOPs Cross-Functional & External Collaboration • Partner closely with GCSO SMEs, Quality, Regulatory, and CROs to ensure alignment on regulatory expectations., • Track and follow up on regulatory assessments, actions, and outcomes. Audit Host & Audit Coordination • Act as Audit Host for internal Quality Audits impacting GCSO., • Work with the Auditing team to coordinate audits and engage relevant SMEs and functions., • Support SMEs during audits by facilitating responses to auditor questions., • Coordinate post-audit activities, including responses to findings, CAPAs, and closure activities, until audits are closed. What This Role Is Not • Not an auditor or audit creator, • Not a primary SOP author, • Not a traditional Regulatory Affairs submission role This role is focused on regulatory intelligence, coordination, oversight, and governance. Required Experience & Skills • Proven experience in Regulatory Intelligence within pharma, biotech, or a CRO environment, • Strong knowledge of GCP, global regulatory frameworks, and country-specific regulations, • Experience working with CROs and understanding outsourced clinical models, • Experience supporting or coordinating audits and inspections, • Ability to assess regulations and translate them into operational impact, • Strong stakeholder management, communication, and organizational skills Nice to Have • Experience within Clinical Supply / GCSO environments, • Familiarity with RIN tools or regulatory tracking systems, • Experience coordinating CAPAs or inspection readiness activities Interested? Apply now for immediate consideration or contact Lloyd Broomes – We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Business providing Global Staffing services.
