Sr. Manager, Regulatory Affairs CMC

About CTMC

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, located in the heart of the Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, and TCR-T. Our expert team collaborates closely with MD Anderson's research and clinical faculty, bringing impactful cell therapies to cancer patients.

Since inception in May 2022, our team has filed six INDs and have received approval, without delay, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in two years, enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.

Our growing, state-of-the-art, 60,000 sq. ft. industrial facility in the Texas Medical Center is staffed by an integrated team of 94 industry veterans and academic scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our organizational goals.

At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure to inspire professional growth and satisfaction. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission to accelerate cell therapies from bench to bedside for patients who need them. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission.

Summary :

Reporting to the Head of Regulatory Affairs, the Sr. Manager, Regulatory Affairs CMC will be responsible for contributing to CMC strategies as well as coordinating many aspects of CMC regulatory submissions. This person will work closely with the development team, particularly with the Process Development, Analytical Development, Quality Control, Manufacturing, and Quality groups to define and contribute to the CMC strategy in development programs at CTMC. CTMC has a unique, flexible and value-added partnership model with biotech companies and MD Anderson Cancer Center. The role will be a central player in this nexus and ensure clear communication of roles and responsibilities across the partners to enable efficient execution of IND-enabling activities, IND submissions and lifecycle management.

Responsibilities

• Supports or leads regulatory CMC strategy development, planning, and implementation for multiple programs at CTMC.
• Participates and contributes on cross-functional internal and joint project teams in providing regulatory CMC guidance throughout the lifecycle of product development.
• Prepare, coordinate, author, review, and maintain CMC content in regulatory submissions (e.g., IND, DMF, amendments, annual reports, meeting packages) within target timelines.
• Identify risk areas and develop alternative courses of action including anticipation of regulator responses and development of contingency plans in concert with technical functions.
• Prepare technical assessments of CMC source documentation and responses to client technical questions on document content.
• Review / approve change controls related to proposed product / process changes and assessing their impact on specific regulatory requirements.
• Maintain knowledge of CMC regulations / guidelines and apply appropriately to projects.
• Involved in preparation and supports CMC interactions with regulatory health authorities.
• For assigned submissions, responsible for all aspects of publishing submissions and / or submission components and for transmitting to regulatory authorities. This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, transmission, and archiving, as applicable.
• Initiate and / or contribute to local process improvements which have an impact on Regulatory Affairs or other departments.
• Other duties as required.

Qualifications :

Working Conditions, Equipment, Physical Demands

The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands :

Equipment-

Physical Demands-

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.

The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.

Salary : $2