We are seeking a Regulatory Affairs & Pharmacovigilance Manager to lead our RA/PV team and ensure regulatory compliance and robust patient-safety systems across our clinical trials and client projects.
Lead, develop, and support the RA/PV team, managing workloads and serving as the primary regulatory and safety contact for clients.
Oversee clinical trial submissions and communications with Regulatory Authorities and Ethics Committees, and provide regulatory sign-off on key study documents.
Manage safety reporting, including SUSARs, ICSRs via EudraVigilance, PSURs, and ASRs, as well as signal detection, safety databases, and Safety Management Plans.
Act as the EU or Local QPPV, or Deputy, where required, including oversight of the PSMF and RMP.
Ensure GVP compliance and inspection readiness while supporting business development and continuous process improvement.
Degree in Pharmacy, Medicine, Life Sciences, or a related field.
Strong knowledge of ICH-GCP, the EU CTR, FDA regulations, and GVP.
Hands-on experience with regulatory submissions and pharmacovigilance, including EudraVigilance and MedDRA coding.
Experience with PSMFs and RMPs is an advantage.
Proven experience leading teams in a regulated environment.
Analytical, client-focused approach with excellent communication skills.
Fluency in English.