Associate Director of Regulatory Affairs - Remote

Overview

The Associate Director of Regulatory Affairs at Orca Bio is responsible for the development and approval of all US promotional materials, ensuring compliance with regulatory guidelines while supporting business objectives.

In Short

• Lead the development and approval of promotional materials.
• Serve as the promotional regulatory expert.
• Collaborate with marketing, legal, and medical teams.
• Ensure compliance with regulatory guidelines.
• Contribute to post-approval regulatory submissions.
• Interface cross-functionally in a matrixed environment.
• Develop regulatory strategies and submissions.
• Meet overall program objectives and milestones.
• Some travel required as needed.

Requirements

• Experience in regulatory affairs within biotechnology.
• Strong understanding of promotional practices.
• Ability to work in a cross-functional team.
• Excellent communication skills.
• Proven track record in regulatory submissions.

Benefits

• Opportunity to work in a cutting-edge biotechnology company.
• Impactful work in improving patient outcomes.
• Collaborative and innovative work environment.