Senior Regulatory Strategy Manager

A company is looking for a Sr Manager Global Regulatory Strategy to oversee clinical trial activities across multiple programs.

Key Responsibilities :

Serve as the regulatory affairs lead for clinical trial activities, including CTA submissions and agency interactions

Develop tailored regulatory strategies for assigned projects, incorporating clinical, nonclinical, and CMC considerations

Coordinate the preparation and submission of regulatory documents to relevant agencies, ensuring alignment with corporate objectives

Required Qualifications and Education :

Proven experience working within Global Regulatory Teams (GRTs) and cross-functional teams

Strong knowledge of drug development processes, ICH guidelines, and regulatory frameworks

Hands-on experience with INDs, CTAs, IMPDs, and Orphan Drug Designations

Clear understanding of submission content and format requirements