Senior Regulatory Consultant

A company is looking for a Senior Regulatory Operations Consultant to oversee electronic regulatory submissions to global health authorities.

Key Responsibilities :

Lead the assembly, publishing, and quality control of electronic submissions (eCTD and NeeS)

Plan and manage submission timelines, coordinating with global regulatory teams

Ensure technical compliance and manage electronic submission gateways and portals

Required Qualifications :

Bachelor's degree in life sciences, information management, or a related field; advanced degree preferred

Expertise in regulatory operations, particularly eCTD publishing

Proficiency in compiling and submitting regulatory dossiers to EMA, FDA, MHRA, and ANVISA

Familiarity with submission publishing tools such as Veeva or Lorenz docuBridge

Strong understanding of regional publishing requirements and sequence lifecycle management