Consultant, Global Regulatory Affairs

About this role

Responsibilities

• Develop and implement regulatory strategy for early- and mid-stage development programs.
• Compile original submissions including INDs, CTAs, and EOP2 documents.
• Oversee the quality function while collaborating with GMP and GCP consultants.
• Serve as the primary company contact for FDA and other regulatory authorities.
• Ensure all external data complies with required specifications and clinical objectives.