The Company:
My client is a purpose-driven organisation focused on pioneering and commercialising novel health care solutions for individuals with unmet medical needs. With over 30 years of research in their clinical pipeline, they provide patients with new treatment options and extend their expertise into broader health care applications. As a rapidly growing company, they seek candidates who share their entrepreneurial spirit and are excited to contribute to a dynamic, international team working toward impactful results.
The Role:
The Regulatory Affairs Project Manager will be responsible for staying current with regulatory changes in key markets, preparing documentation for New Drug Applications, and managing post-marketing requirements, including market access and IRB submissions. They will also oversee regulatory submissions for clinical programs, orphan drug designation, and labelling/packaging material supply. As part of our client's fast-growing, dynamic international team, this candidate will help deliver impactful health care innovations while working closely with leadership to meet deadlines.
Key Responsibilities: RegulatoryAssist in the development of the ongoing global regulatory strategySubmissions of NDAs and amendmentsApplications and submissions to the FDA as required following post approval obligations and commitments, as well as Prepare response to questions raised by FDAMaintain all approvals by submitting annual updates as needed (example Orphan designations, Investigator Brochure)Support Quality and Pharmacovigilance colleagues in systems managementClinical Trial ApplicationsPrepare and/or collate all documentation to support clinical trial applicationsFile substantial amendments as requiredAssist sites in submitting applications to IRBs, and preparing responses to questions raised by IRBs and updated documentation as requiredMaintain the Investigator Brochure and Investigational Medicinal Product DossierEnsure investigation medicinal product is supplied to the study sites in compliance with all regulatory requirements, including packagingLabelling & PackagingObtain approvals on labelling text and design by competent authoritiesManage packaging material manufacturing and create secondary packaging materialReview and approve contract manufacturer's specifications and packaging documentsQualifications: Post-graduate qualifications in Pharmacy, Biological Sciences, or related disciplineMinimum 5 years pharmaceutical industry experienceProven experience in preparation of New Drug ApplicationsProven experience in regulatory management of centrally approved productsUnderstanding of Orphan Drug requirementsProven understanding of eCTD Modules 1-5Proven experience in labelling, pricing and reimbursement procedures (desirable)Preparation of marketing authorisation applications in eCTD format (desirable)Preparation of CTAs to support clinical trials (desirable)
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