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:
- Regulatory
- Assist in the development of the ongoing global regulatory strategy
- Submissions of NDAs and amendments
- Applications and submissions to the FDA as required following post approval obligations and commitments, as well as Prepare response to questions raised by FDA
- Maintain all approvals by submitting annual updates as needed (example Orphan designations, Investigator Brochure)
- Support Quality and Pharmacovigilance colleagues in systems management
- Clinical Trial Applications
- Prepare and/or collate all documentation to support clinical trial applications
- File substantial amendments as required
- Assist sites in submitting applications to IRBs, and preparing responses to questions raised by IRBs and updated documentation as required
- Maintain the Investigator Brochure and Investigational Medicinal Product Dossier
- Ensure investigation medicinal product is supplied to the study sites in compliance with all regulatory requirements, including packaging
- Labelling & Packaging
- Obtain approvals on labelling text and design by competent authorities
- Manage packaging material manufacturing and create secondary packaging material
- Review and approve contract manufacturer's specifications and packaging documents
Qualifications:
- Post-graduate qualifications in Pharmacy, Biological Sciences, or related discipline
- Minimum 5 years pharmaceutical industry experience
- Proven experience in preparation of New Drug Applications
- Proven experience in regulatory management of centrally approved products
- Understanding of Orphan Drug requirements
- Proven understanding of eCTD Modules 1-5
- Proven 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)
