Sr Freelance Regulatory Affairs Consultant - USA - Orphan Indications
Senior Freelance Regulatory Affairs Consultant - USA - Orphan Indications - CTAs/INDs to FDA - Home based Following some exciting developments with one of Upsilon Global's trusted CRO partners and their emigration to the US, our client is now seeking regulatory support for a portfolio of rare diseases and orphan indications to be submitted to the FDA. If you have experience in the preparation and creation of CTAs and INDs in rare indications such as Cystic Fibrosis or Phenylketonuria, our client is very interested in speaking with you. Backround Details confidential, more information available upon request. This small but well-established CRO have begun making the transition over to North America, having recently employed business and clinical development consultants to initiate their primary operational tasks. They now need initiate their orphan drugs submissions to the FDA and need expert guidance on how to do so. There's a large portfolio of compounds, so they are looking for a long-term engagement with an American Regulatory specialist. Main Roles Responsibilities: - Design and create Clinical Trial Applications for INDs in orphan indications - Provide advice on submission strategy & contribution to substantial & non-substantial decisions for amendments, safety reporting processes, distribution and supply issues, GCP & safety issues and country specific requirements - Attend CTA submission team meetings as American regulatory Affairs representative - Provide ad hoc support for CTA related projects throughout the organisation - Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities; substantial amendments, end of trials notifications - Support inspection readiness activities when applicable - Ensure approved company CTA processes are followed within agreed timelines - Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met - Monitor key project milestones, communicate changes to assigned stakeholders and management as agreed in company procedures - Participate in process improvement initiatives - Support SOP reviews and updates as require Essential Experience: - Must be an expert in American regulatory submissions - Ideally with experience in the creation and preparation of CTAs in orphan and rare indications, such as Cystic Fibrosis and Phenylketonuria, Metabolic Disorders - Experience working with small CROs beneficial For further information on this opportunity and to learn of similar positions, please contact Upsilon Global on '44. 20. 3. 87. 5.9. 966' or email ' applications (at) upsilonglobal . com'