Intellia Therapeutics – Global Regulatory Affairs Postdoctoral Research Fellow
Core
Two-year Regulatory Affairs fellowship for PharmD graduates to develop regulatory strategies, advertising, promotion, and labeling (APL) for CRISPR-based gene editing therapies.
Role type
Postdoctoral Research Fellow (Regulatory Affairs)
Builds
Regulatory strategies, marketing materials, and regulatory filings for gene editing therapeutics (via careerplan.io/jobs/R142346-intellia-therapeutics-global-regulatory-affairs-postdoctoral-research-fellow-at-northeaste)
Domain
Biotechnology / Gene Editing / Regulatory Affairs
Required skills
Regulatory strategy development, medical communications, regulatory filing preparation, agency meeting preparation, cross-functional collaboration, trend analysis in regulatory environments
Preferred skills
Electives in Regulatory Affairs, knowledge of gene editing and CRISPR, leadership abilities
Technologies
None stated
Responsibilities
Develop regulatory strategies for product development phases, collaborate on medical communications and regulatory filings, prepare annual reports and amendments for INDs/BLAs, lead development of regulatory trend research methods, prepare for agency inspections and audits, present to MLR committees
Seniority
Postdoctoral Fellow (Entry-level industry training)
