Upvote
Downvote
Associate Director Regulatory Affairs
Share Job
- Suggest Revision
Full-time
- An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for initiating and conducting clinical trials and securing marketing authorization.
- Contribute to strategic planning and implementation of clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization.
- Interact with the FDA, EMA, PMDA, and other regulatory agencies to seek scientific and regulatory advice and obtain required approvals.
- Provide strong cross-functional leadership for global filings including authoring/reviewing sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, as well as their amendments, in conformance with local regulatory requirements.
- Provide regulatory leadership for due diligence activities, partnering activities, and product/company integrations.
Active Job
Updated TodaySimilar Job
Relevance
Active