Principal Regulatory Affairs Specialist

Job Summary

A company is looking for a Principal Regulatory Affairs Specialist.

Key Responsibilities

• Lead regulatory affairs on cross-functional teams for product line submissions and registrations
• Drive regulatory strategy for high-volume markets and coordinate global product registrations
• Conduct regulatory change assessments and support lifecycle projects for drug and medical device products

Required Qualifications

• Bachelor's Degree or higher and ten years of regulatory affairs experience in the drug and/or medical device industry
• Experience with regulatory submissions and technical documentation for drug and medical device products in multiple regions
• Experience authoring regulatory strategies and change assessments
• Experience with product labeling compliance for global regulatory requirements
• Experience with dental products, including NDA and OTC monograph drugs and medical devices