Manager, Regulatory Affairs

Role Overview

• Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs
• Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications
• Provides regulatory expertise to labeling changes and to submission teams on specified projects and topics
• Provides input to senior Regulatory Affairs professionals in the preparation of country specific labeling
• May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses
• Participate in group meetings and local and global product submission team meetings and present project status updates

Requirements

• BS and 7+ year of experience in Regulatory Affairs or other relevant industry experience
• OR MS and 5+ years of experience in Regulatory Affairs or other relevant industry experience
• Degree in a scientific field is preferred
• Excellent organization skills and ability to work on a number of projects with tight timelines is required
• Excellent verbal and written communication skills and interpersonal skills are required
• In-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories

Benefits

• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off
• company-sponsored medical, dental, vision, and life insurance plans