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
If you resonate with our 4i values above and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
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.
Apply today! http://jobs.thermofisher.com (bolded) 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.