ABOUT:
Are you passionate about advancing treatments for life-changing conditions? This global specialty pharmaceutical leader is transforming the landscape of genetic, metabolic, and systemic disorders. With a cutting-edge focus on melanocortin technology, they are on a mission to build a world-class melanocortin house-bringing hope to patients with life-threatening and acute conditions. With 10 products in the pipeline, ranging from pre-clinical to commercial, the company is looking to bring on a Regulatory Manager to their US site (California; However, this role can be remote)*.
Key Responsibilities:
- 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
- Prepare and/or collate all documentation to support clinical trial applications
- Assist sites in submitting applications to IRBs, and preparing responses to questions raised by IRBs and updated documentation as required
- Ensure investigation medicinal product is supplied to the study sites in compliance with all regulatory requirements, including packaging
- Manage packaging material manufacturing and create secondary packaging material
- Review and approve contract manufacturer's specifications and packaging documents
Qualifications:
- 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
- Preparation of marketing authorization applications in eCTD format
- Proven experience in labelling, pricing and reimbursement procedures (desirable)
- Preparation of CTAs to support clinical trials (desirable)
