What are the responsibilities and job description for the Regulatory Affairs Manager position at EPM Scientific - Phaidon International?
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 :
J-18808-Ljbffr
