Defender Pharmaceuticals is searching for a Sr. Manager Regulatory Affairs to lead regulatory and product development activities. This is a great opportunity to leverage your initial RA experience into an RA leadership position in an early-phase small-to-medium sized company, where you can direct and manage a project but are able to rely on external experts and consultants as needed to fill knowledge gaps.
This position is based in St. Louis but can be remote for the right candidate.
Responsible for global regulatory affairs strategy for assigned projects covering the development, registration and post approval phases, and acts as liaison with the health authorities including the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) review divisions, and other national authorities. Works closely with other functional areas to develop regulatory strategies and timelines, including regulatory operations, project management, translational sciences, clinical development, manufacturing, pharmacovigilance, legal, and medical affairs. The desired candidate will have familiarity with clinical development. Competitive pay.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Provides advice and direction including identifying and assessing regulatory risks regarding regulatory requirements and strategies.
Develops and executes effective proactive regulatory strategies and plans.
Authors INDs, regulatory meeting packages, meeting requests, orphan drug designation requests, and other regulatory correspondence.
Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact the Company’s development programs. Advise personnel in other departments regarding their applicability and impact.
Leads meetings with Regulatory Authorities (e.g., Pre-IND, End of Phase 2, Pre-NDA, Scientific Advice and national advice) including meeting requests, meeting background documents and action plan following such meetings.
Participates in the development of SOPs.
Establishes standards for compliance of regulatory submissions with health authority laws, regulations and guidance documents.
Maintains knowledge of the laws, regulations and guidelines governing drug development and approval.
Manages and reviews safety reports and submissions.
Manages contract manufacturers.
Manages clinical trial sites and their selection.
Bachelor’s and/or Master’s degree in scientific, health care or related field or equivalent. MD/PhD preferred, but not required with appropriate experience.
A minimum of 5 years of drug development experience, with 3+ years of regulatory experience.
Previous management experience is preferred. Must demonstrate the ability to work through others.
Must demonstrate understanding of drug development and knowledge of FDA requirements. Working knowledge of scientific principles.
Direct experience with FDA required and international experience preferred. Clinical development experience strongly preferred.
Experience with 505(b)2 submissions preferred.
Highly organized with attention to detail. Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills.
Has familiarity with MS Word, MS Excel, Adobe Acrobat and PowerPoint applications. Working knowledge of electronic publishing/file management system.
Moderate travel as needed.
Internal Number: 001
About Defender Pharmaceuticals
Defender Pharmaceuticals is a late-stage pharmaceutical development company focused on the discovery, development, and marketing approval of anti-vomiting and anti-nausea compounds. Defender is expanding into early stage trials in neurological indications.