Senior Regulatory Manager

Job Summary

Experienced regulatory professionals will find a full-time salaried Senior Regulatory Manager opportunity responsible for leading regulatory submissions, ensuring compliance with FDA regulations, and collaborating with cross-functional teams in a remote setting.

Key responsibilities

• Manage and oversee the preparation and submission of regulatory documents to the FDA and other regulatory agencies
• Ensure compliance with applicable regulations and guidelines throughout the product lifecycle
• Collaborate with internal teams to develop regulatory strategies and provide guidance on regulatory requirements

Required qualifications

• Advanced degree in life sciences or a related field
• Minimum of 5 years of experience in regulatory affairs, preferably in the pharmaceutical or biotechnology industry
• Strong knowledge of FDA regulations and submission processes
• Experience with clinical trial applications and marketing applications
• Proven track record of successful regulatory submissions and interactions with regulatory agencies