Senior Regulatory Manager

Overview

• Lead regulatory strategy development and implementation for pharmaceutical products in development and post-approval stages.
• Coordinate and manage scientific and regulatory submissions, including INDs, NDAs/BLAs, IMPDs, and MAAs.
• Serve as the scientific representative on project teams, contributing to strategic decision-making.
• Provide regulatory support for analytical method development, validation activities, and stability programs.
• Ensure compliance with changing regulations and health authority actions.
• Collaborate with global offices and teams to ensure regulatory alignment and effectiveness.
• Work closely with manufacturing and QA/QC teams to evaluate regulatory impacts of proposed changes.
• Contribute to lifecycle management of regulatory dossiers and submissions.

Key Responsibilities & Duties

• Manage planning, preparation, and submission of regulatory dossiers in compliance with global standards.
• Evaluate regulatory impacts of manufacturing, analytical, and quality changes.
• Act as the primary liaison with health authorities for assigned products.
• Draft and coordinate Chemistry, Manufacturing, and Controls (CMC) sections within eCTD format.
• Provide scientific and regulatory support for method development and validation activities.
• Collaborate with global CMOs and CROs to ensure regulatory compliance.
• Monitor and adapt to changing regulatory requirements and health authority actions.
• Support GLP and GMP compliance, including on-site inspections.

Job Requirements

• Bachelor of Science (BS) in Chemistry, Biotechnology, or related field; advanced degree preferred.
• Minimum 7 years of experience in regulatory affairs, with 8 years preferred.
• Proven expertise in CMC regulatory strategy and eCTD authoring.
• Experience with FDA, EMA, and Health Canada regulatory requirements.
• Knowledge of GLP and GMP compliance, including prior inspection experience.
• Ability to interpret scientific data and technical instructions effectively.
• Experience working with global CMOs and CROs.
• Familiarity with Veeva systems is a plus.