Senior Regulatory Strategy Manager

Job Summary

A company is looking for a Senior Regulatory CMC Strategist.

Key Responsibilities

• Develop and implement global regulatory strategies for clinical development programs
• Provide regulatory guidance in partnership with cross-functional teams throughout the product development lifecycle
• Engage with regulatory agencies to facilitate product approvals and address inquiries

Required Qualifications

• Bachelor's or advanced degree in a relevant scientific or regulatory discipline
• Proven experience in regulatory strategy within the pharmaceutical or CRO industry
• In-depth knowledge of global regulatory requirements for drug development and submissions
• Strong analytical and strategic thinking skills
• Ability to navigate complex regulatory scenarios