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

Regulatory Toolkit; North Carolina; On-site; USD 150,000 - 190,000; Full time

Job summary

Thermo Fisher Scientific in the United States seeks a seasoned CMC Regulatory Lead to steer global regulatory strategy for biological products and ensure compliant dossier delivery to FDA and Health Canada. You will own Module 3 content, coordinate cross-functional teams, and drive timely regulatory submissions.

The role requires a strong background in biologics CMC, regulatory intelligence, and lifecycle management, with capability to harmonize regional requirements and maintain post-approval

Qualifications

• Master's or PhD in biotechnology, pharma sciences or bioengineering.
• Global regulatory knowledge (EMA, ICH) for biologics.
• Proven CMC regulatory submissions leadership for biologics.
• Understanding of manufacturing, comparability and analytics.
• Strong project management and cross-functional collaboration.
• Excellent written and verbal communication in cross-border teams.

Responsibilities

• Lead development and execution of CMC regulatory strategies for biologics.
• Serve as SME on biologics and guide regulatory submissions to FDA/Health Canada.
• Coordinate with R&D, Quality, Manufacturing and Global Regulatory to align submission strategies.
• Oversee preparation, review and submission of CMC sections (Module 3) for biologics.
• Author and maintain CTD Module 3 content for regulatory filings.
• Respond to authorities' questions and deficiencies for CMC filings.

Skills

CMC strategy

Biologics expertise

Regulatory submissions

Cross-functional leadership

Project management

Regulatory communication

Education

Advanced biotech degree

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

CMC Regulatory Strategy and submissions for Biologicals

• 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.

Knowledge, Skills, and Abilities

• Master's degree or PhD in biotechnology, pharmaceutical sciences or bioengineering, with relevant expertise in CMC development and CMC regulatory for biological products (min 10 yrs)
• 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.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. 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. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.