Director, Global Regulatory Affairs & Clinical Safety Business Development

About the role

The incumbent will represent Regulatory Affairs on business development transactions from deal initiation through potential signing. Responsibilities include overseeing staff managing the business development stages of strategy, evaluation, due diligence, contracting, implementation support, and maintenance of regulatory activities.

Responsibilities

• Oversight of people management for supporting a range of Business Development opportunities
• Assumption of responsibilities for employee development and management
• Collaboration with Global Regulatory Affairs and Clinical Safety, Corporate Business Development, Clinical Research, Commercial, Manufacturing, and other groups
• Support for the development of new Business Development agreements with a focus on Regulatory aspects
• Maintenance of existing agreements that require updating as the partner relationship evolves
• Overseeing multiple projects with potentially complex integration points and fast-paced timelines
• Assisting in assessing problem situations, gathering and processing relevant information, generating possible solutions, and making recommendations or resolving issues

Requirements

• Bachelor's degree in a related field
• At least 7 years' experience in the pharma industry or adjacent fields such as Health Authorities
• Advanced degree in Regulatory or other science discipline preferred

Skills

• Adaptability
• Change Management
• Detail-Oriented
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Compliance Audits
• Regulatory Experience
• Regulatory Strategy Development
• Regulatory Submissions
• Strategic Planning
• Strategic Thinking