Our client, a national consulting firm specializing in the clinical arena, is seeking a Regulatory Affairs Specialist to join their expanding team.
You will manage multiple regulatory programs for biotech and pharma sponsor companies. These responsibilities may include the full scope of regulatory project management or individual components based on the contracted scope of responsibilities. You will be responsible for developing regulatory strategy and the preparation/review of regulatory submissions including meeting requests, INDs, CTAs, NDAs, MAAs, and ANDAs as well as authoring annual reports, amendments, and supplements. You may also prepare and publish eCTD applications and have direct interactions with the FDA.
Bachelor s degree in life science, business or management (advanced degree is a plus) and 6-10 years of experience in a biotech or pharma setting. Regulatory Affairs Certification (RAC) is a plus. You will need broad experience in regulatory affairs (including clinical trial applications, global marketing authorizations and post approval life cycle management) and the ability to support several projects for different client engagements simultaneously. The ideal candidate will also have experience supporting program level strategic planning activities spanning from pre-IND through marketing approval. You ll be expected to be highly proficient in the MS Word, Excel, Project, and PowerPoint.
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