Director, Regulatory Affairs Strategy

A company is looking for an Associate Director/Director, Regulatory Affairs (Strategy). Key Responsibilities Support the development and implementation of regulatory strategies for drug, biologic, and gene therapy product advancement Represent Regulatory Affairs on cross-functional project teams to resolve complex project issues Manage and prepare regulatory submission documents, ensuring timely delivery to regulatory agencies Required Qualifications Bachelor's degree in life sciences or related scientific discipline; advanced degree preferred Minimum of 6 years of experience in Regulatory Affairs strategy Demonstrated leadership ability with strong critical thinking and analytical skills Strategic and operational experience in managing regulatory submissions Ability to maintain knowledge of the shifting regulatory landscape

May 18, 2025 - 19:10

A company is looking for an Associate Director/Director, Regulatory Affairs (Strategy). Key Responsibilities Support the development and implementation of regulatory strategies for drug, biologic, and gene therapy product advancement Represent Regulatory Affairs on cross-functional project teams to resolve complex project issues Manage and prepare regulatory submission documents, ensuring timely delivery to regulatory agencies Required Qualifications Bachelor's degree in life sciences or related scientific discipline; advanced degree preferred Minimum of 6 years of experience in Regulatory Affairs strategy Demonstrated leadership ability with strong critical thinking and analytical skills Strategic and operational experience in managing regulatory submissions Ability to maintain knowledge of the shifting regulatory landscape