CMC Regulatory Strategist

Job Summary

A company is looking for a CMC Regulatory Strategist.

Key Responsibilities:

• Support and advise on CMC and regulatory components of integrated development programs
• Provide leadership and guidance in CMC regulatory strategy and product development
• Manage project budgets, timelines, and deliverables while ensuring effective communication with the team and senior management

Required Qualifications:

• PhD/PharmD or equivalent with a minimum of 12 years of relevant experience
• Experience with FDA regulations; knowledge of ex-US regulatory authorities is a plus
• Strong project management skills with in-depth CMC regulatory experience
• Ability to build effective teams and motivate others
• Proficient in relevant software such as MS Project, Excel, and PowerPoint