Independently prepare IND Modules for routine submissions.
Support regulatory affairs leadership in preparation of complex submissions, using regulatory intelligence to support regulatory strategies and other regulatory deliverables (e.g., Orphan Designation Applications, Fast Track and Breakthrough Designations, Briefing Packages, etc.).
Perform thorough independent background research through all pertinent search engines for further in-depth research efforts related to medical and regulatory documents, filings, and/or submissions.
Ensure that documents appropriately evaluate and present data and methodology, accurately reflecting the information provided in scientific literature available in the public domain.
Navigate and obtain information for projects from all available resources.
Produce timely, scientifically accurate data summaries, ensuring documents are appropriate for inclusion in final reports and submissions to client and/or FDA.
Construct documents in a manner consistent with applicable regulations and guidance and client strategic intent, conforming to Premier Consulting’s internal Standard Operating Procedures (SOPs).
Serve as Regulatory representative in department discussions and present issues, challenges, and potential solutions accordingly.
Interface with international affiliates on regional regulatory strategy and implementation plans.

Master’s degree, or international equivalent from an accredited institution, in a science or health related field; PhD or PharmD preferred.
3+ years of experience working in a CRO, pharmaceutical biotechnology, consulting, regulatory affairs, or device/diagnostics industry; industry experience may be considered in lieu of an advanced degree and a post advanced degree fellowship may be considered in lieu of industry experience.
Strong scientific verbal and writing skills.
Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
Ability to communicate and interact effectively within the department, across departments and on project team(s).

Regulatory Strategy Associate

Key skills