Director Regulatory Affairs Strategy - Remote

Overview

The Director Regulatory Affairs Strategy provides global regulatory oversight and project leadership of assigned development products and reports to the Vice President Regulatory Affairs. The incumbent will be responsible for contributing to and implementing regulatory strategies and plans to expedite global product development, managing regulatory communications/interactions with health authorities, and ensuring compliance with applicable regional regulations.

In Short

• Provide global regulatory oversight and project leadership.
• Contribute to and implement regulatory strategies.
• Manage regulatory communications with health authorities.
• Ensure compliance with regional regulations.
• Interface with cross-functional Development teams.
• Develop and implement global regulatory strategy.
• Prepare and lead milestone development meetings.
• Review and communicate regulatory requirements.
• Assist in the development of standard operating procedures.
• Monitor company progress toward regulatory commitments.

Requirements

• Bachelor’s degree in a life sciences discipline; advanced degree preferred.
• Minimum 8 years of progressive pharmaceutical Regulatory Affairs experience.
• Direct experience in preparation and submission of global applications.
• Experience negotiating with regulatory authorities.
• Knowledge of GXP/ICH guidelines and global regulations.
• Strong written and verbal communication skills.
• Excellent strategic planning and project management skills.
• Ability to work in a dynamic environment.

Benefits

• Vibrant small-company culture.
• Competitive salary and benefits package.
• Opportunities for professional growth and development.