Client Dedicated CMC Regulatory Manager/Senior Manager - US & Canada

Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office

About the role

This is a position to lead and execute global CMC regulatory strategy and submissions, ensuring the delivery of high-quality CMC dossiers in full compliance with US & CA regulatory requirements.

Responsibilities

• Lead the development and execution of CMC regulatory strategies for biological products.
• Serve as the subject matter expert on biologics, providing CMC regulatory guidance for the preparation of regulatory submissions to the regional agencies (FDA, Health Canada).
• Act as the primary liaison for CMC regulatory matters related to biologicals, collaborating with global teams (R&D, Quality, Manufacturing, Global Regulatory) to align on submission strategies.
• Oversee the preparation, review, and submission of CMC sections (Module 3) specific to biological products, in regulatory filings such as MAAs and variations.
• Author, compile, and maintain CTD Module 3 content as applicable.
• Coordinate responses to CMC-related questions and deficiencies raised by the Health Authorities.

Post-Approval Compliance and Lifecycle Management

• Perform regulatory impact assessments for CMC change controls and quality events, with a focus on U.S. FDA and Health Canada regulatory requirements and reporting classifications.
• Lead the preparation, authoring, review, and coordination of Annual Reports for U.S. and Canadian marketing applications, ensuring accurate reporting of post-approval CMC changes and Commitments.
• Lead the preparation, authoring, review, and coordination of Yearly Biologic Product Report (YBPR) for Canadian marketing, ensuring accurate reporting of post-approval Quality changes.
• Author, review, and compile Module 1 documentations for commercial submissions, including region-specific administrative and quality components for both US and Canada submissions. Region-specific documents include, but are not limited to, FDA Forms, the Reviewer’s guide for US submission, and the Note to Reviewer for Canadian submissions as applicable under the Post-NOC guidance.
• Lead the CMC regulatory management and dossier authoring of post-approval changes, including manufacturing process changes, site transfers, and formulation updates for biological products.
• Ensure continuous compliance with regulatory requirements throughout the lifecycle of the biological product, managing variations and renewals.
• Monitor and assess regulatory guidance related to biologics and provide strategic input into regulatory filings.

Requirements

• Master's degree or PhD in biotechnology, pharmaceutical sciences or bioengineering, with relevant expertise in CMC development and CMC regulatory for biological products (minimum 10 years).
• Extensive knowledge of global regulations including EMA regulations, ICH guidelines, and specific CMC regulatory requirements for biologics.
• Proven experience leading CMC regulatory submissions for biological products, including initial MAA submissions and post-approval lifecycle management.
• Strong understanding of biologics manufacturing, characterization, comparability, and analytical testing requirements.
• Excellent project management skills with the ability to manage complex projects and timelines.
• Strong communication and interpersonal skills, with experience working in cross-functional and international teams.

About Us

Our 4i Values: Integrity – Innovation – Intensity – Involvement

Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.