Regulatory Submissions Manager

A company is looking for a Regulatory Submissions Manager to support high-priority regulatory activities in the biopharma sector.

Key Responsibilities

Lead and coordinate the preparation, formatting, and submission of regulatory documents for INDs / CTAs and NDA amendments

Manage document lifecycle and submission tracking using Veeva RIM

Collaborate with cross-functional teams to ensure timely and accurate submissions

Required Qualifications

Bachelor's degree in life sciences or related field; advanced degree preferred

Minimum 5 years of experience in regulatory operations or submission management in the biotech / pharma industry

Proven experience with IND and NDA submissions

High proficiency in Veeva RIM

Strong knowledge of eCTD structure and FDA / EMA submission requirements