Thermo Fisher Scientific

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

Thermo Fisher Scientific • $125K — $150K *
US-Anywhere
+ 2 other locationsRemote
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Master's degree or PhD in biotechnology, pharmaceutical sciences, or bioengineering
  • Minimum of 10 years of experience in CMC development and regulatory for biological products
  • Deep understanding of global regulations, including EMA and ICH guidelines
  • Proven track record of leading CMC regulatory submissions and lifecycle management for biological products
  • Expertise in biologics manufacturing, characterization, and analytical testing
  • Strong project management capabilities and experience managing complex timelines
  • Excellent communication skills, with the ability to collaborate effectively across global teams.

Responsibilities

  • Lead and execute CMC regulatory strategies for biological products
  • Serve as a subject matter expert for regulatory submissions to FDA and Health Canada
  • Coordinate with global teams on submission strategies for biologicals
  • Oversee preparation and submission of CMC sections for regulatory filings
  • Compile and maintain CTD Module 3 content as needed
  • Manage responses to regulatory authorities regarding CMC questions
  • Ensure compliance with regulatory requirements during the lifecycle of biological products.

Benefits

  • Comprehensive health and wellness programs
  • Flexible work schedule options
  • Opportunities for professional development and training
  • Collaborative workplace culture
  • Supportive management and leadership team
Full 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.


About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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