Senior Regulatory Affairs Manager (Remote)
Our client is a large biodefense and pharmaceutical company who is currently working on a nasal spray product. They are hoping to complete an IND submission on this combination product. They are looking a senior level regulatory consultant to come in and act as the regulatory lead and primary contact for the project team
The consultant will be coming on board to act as the regulatory lead for the program. They will provide guidance and/or responses to questions to the team with regard to regulatory strategy for non clinical, clinical and CMC.
Review and comment on non Clinical, Clinical and CMC, or general project management documents (i.e development plans, protocols, meeting minutes) as required by SOP and/or requested by stakeholders (as appropriate). Additional deliverables / requests that may arise through the project team or via the various sub teams. As well they will lead health authority meetings. From there they will develop strategy, oversee authoring, review and adjudication activities pertaining to the generation of the meeting request letter and briefing package to ensure timely and high quality submission.
Their responsibilities will entail preparing for face to face meetings. Post submission they will evaluate and interpret FDA feedback and provide guidance on overall impact / risks to the program. Lead Clinical Submissions (IND). Provide guidance to SMEs on overall content strategy for non clinical, clinical and CMC sections.
Oversee authoring, review and adjudication activities to ensure timely and high quality submission. Identify potential risks, mitigations and communicate them in a timely manner to management. Complete and submitted IND Submission. Oversee responses to any FDA questions (as applicable).
Job Type: Contract