Regulatory Affairs Specialist V-41593
- This individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation, and editing of periodic regulatory reports (i.e. DSURs, orphan annual updates, NDA annual reports, PBRERs).
- With oversight and guidance, contributes to the generation of product regulatory strategy documents (for products in phase 1-3 clinical development), labeling updates for marketed products, generation of FDA meeting requests and corresponding briefing materials, and other tasks as needed.
Qualifications
- Working knowledge of FDA and ICH requirements for standard regulatory documents and their maintenance.
- Excellent written and verbal communication skills, with ability to organize and manage multiple priorities.
- Proficiency in MS Word, Excel, and PowerPoint.
- Self-starter with the ability to work independently but seeking out guidance as needed.
- Technical aptitude to work across multiple information systems and databases with ability to troubleshoot.
- Sense of urgency and perseverance to achieve results.
- Bachelor's degree and at least 5 years in Regulatory Affairs or relevant industry experience, or
- Master's, PharmD, PhD degree and 3 years in Regulatory Affairs or relevant industry experience.
Additional Information
Need someone that has worked on a regulatory team, preparing regulatory documents. Candidates will need to understand the content; really looking at regulatory strategy and drug development and synthesizing that information for reports.