Senior Manager – Regulatory Project Management – Global Regulatory CMC

Senior Manager – Regulatory Project Management – Global Regulatory CMC

Requirements

• Bachelor’s degree in life sciences, chemistry, pharmacy, biochemistry, or a related field
• Minimum of 8 years of experience in Regulatory Affairs/ or Project Management with a focus on CMC
• At least 5 years in a project management role
• Experience with regulatory submissions for biologics, biosimilars, or small molecules (IND, NDA, MAA, BLA, variations, etc.)
• Strong understanding of CMC-related regulatory requirements across major global markets (FDA, EMA, ICH, etc.)
• Previous experience in managing processes for submissions within cross-functional teams and leading complex projects with global scope

Responsibilities

• Lead and oversee the tactical management of CMC regulatory submissions for assigned drug development programs
• Ensure the successful execution of regulatory submission milestones for CMC documentation, including Investigational New Drug (IND) applications, Biologics License Applications (BLA), Marketing Authorization Applications (MAA), and variations
• Manage the preparation, review, and submission of CMC sections for regulatory filings (IND, CTA, NDA, MAA, BLA, etc.) in compliance with global regulatory requirements and support the integration of project plans
• Coordinate regulatory responses to Health Authority inquiries related to CMC filings
• Collaborate closely with Reg CMC and Technical Development to ensure regulatory CMC deliverables are aligned with product development and submission timelines
• Facilitate effective communication across functional teams to ensure consistency in regulatory submissions and approvals
• Oversee the planning, tracking, and execution of CMC regulatory project timelines, identifying and mitigating potential risks that may impact project deliverables
• Manage efforts to streamline regulatory CMC processes and ensure effective coordination between teams and external partners
• Coordinate the timely resolution of CMC regulatory issues, including the preparation of risk assessments and contingency plans
• Maintain up-to-date knowledge of regulatory guidelines, CMC-related regulations, and health authority requirements globally
• Provide training and development opportunities for junior regulatory staff on CMC regulatory submission matters and best practices

Preferred Qualifications

• Additional certification in regulatory affairs (e.g., RAC – Regulatory Affairs Certification) is a plus