Regulatory Affairs Specialist

A company is looking for a Regulatory Affairs Specialist.

Key Responsibilities

Support execution of pharmaceutical regulatory strategy and submissions for assigned products

Ensure product documentation complies with regulatory requirements for agency filing

Prepare documentation for meetings with Regulatory Authorities and manage archival of Health Authority Correspondences

Required Qualifications

Bachelor's degree required, preferably in life sciences or health-related disciplines; Master's degree preferred

2+ years of relevant pharmaceutical industry and regulatory experience

Knowledge of FDA regulations and guidance

Understanding of pharmaceutical CMC, nonclinical, and clinical development

Ability to partner within regulatory and cross-functional teams