Regulatory Affairs Project Manager

Job Summary

To support innovative clinical development, the remote CMC Project Manager will oversee regulatory affairs delivery, coach team members, and drive continuous improvement while participating in strategic drug development and regulatory activities.

Key responsibilities:

• Provide regulatory expertise in strategic drug development across multiple areas
• Prepare strategic development and submission plans
• Act as a trusted partner in business development activities and generate new business opportunities

Required qualifications:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Minimum of 7 years of regulatory affairs experience, including supervisory experience in the pharmaceutical/CRO industry
• Demonstrable experience in developing regulatory strategies and interacting with regulatory agencies
• Strong organizational skills with the ability to manage multiple tasks effectively
• Excellent presentation and interpersonal skills