Immatics US, Inc. is a highly innovative biopharmaceutical company headquartered in Houston, TX (USA) and co-launched, together with MD Anderson Cancer Center, as a subsidiary of Immatics Biotechnologies GmbH, headquartered in Germany. Our goal is to deliver adoptive cellular immunotherapies for novel cancer targets in indications with highly unmet medical need. Immatics is the leading biopharmaceutical company in the development of cancer immunotherapeutics based on tumor-associated peptides (TUMAPs) that constitute the most relevant targets for all T-cell based immunotherapies.
Immatics US pipeline is based on adoptive cellular therapy (ACT). ACT has demonstrated dramatic clinical effects in melanoma and certain blood cancers. However, relevant and safe targets to translate these initial successes to other cancer types are critically lacking to the field. ACT has the potential to induce significant clinical benefits including rapid clinical responses and can potentially be developed up to FDA marketing approval within few years.
Immatics US is headquartered in Houston with a significant R&D infrastructure. Immatics US has a team of highly qualified research, medical and business professionals and we are looking for team members who constantly strive for excellence and whose motivation is driven by their dedication to innovation and science. We offer a competitive salary based on experience, and a comprehensive benefits package.
Director of Regulatory Affairs
The primary purpose of the Director of Regulatory Affairs Position is to manage and execute the regulatory activities including submissions, departmental projects, and being the primary contact for interaction with governmental agencies. This position will be responsible for providing Regulatory guidance to the company.
- Lead and manage the US Regulatory Affairs Department.
- Direct aspects of the regulatory process including strategy (agency interactions, application planning), operations (meeting request, background packages, IND through BLA submissions), and regulatory CMC in collaboration with the company senior leadership
- Develop and recommend regulatory strategies for Immatics’ cell therapy products and companion diagnostic devices to senior management, update based upon regulatory changes.
- Develop overall timelines and plans by working with team members in Regulatory Affairs, Research and Development, Quality Assurance, and Clinical Operations to ensure regulatory requirements are properly covered and implemented as part of product development plans.
- Work with Medical Colleagues to develop new protocols and related documents and manage protocol amendments and safety updates
- Manage strategic vendors that support Regulatory Affairs
- Ensure compliance with regulatory requirements and timely preparation of organized and scientifically valid applications.
- Arrange, prepare for, and lead meetings with FDA and lead internal discussion to prepare for such meetings).
- Interact as the company representative with external contacts for regulatory functions, including FDA, IRBs and scientific review boards, clinical and business cooperation.
- Lead and oversight of all regulatory operational processes and tasks, including authoring and compilation of regulatory submissions, coordination of regulatory CROs, TMF handling, trial insurance, clinicaltrials.gov registration.
- Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements
- Mentor, guide, and train direct reports and cross functional team members to increase regulatory affairs awareness.
- Other duties as required.
Qualifications and Requirements
To be considered for this position, applicants must meet the following requirements:
- Minimum of 7 years of experience in regulatory affairs in pharmaceutical development in preclinical and clinical stage; experience in oncology biologics including adoptive cell therapy is a clear plus.
- Experience with all aspects of the regulatory process including strategy (agency interactions, application planning), operations (meeting request, background packages, IND through BLA submissions), and regulatory CMC (minimum of supervision experience).
- Experience with FDA CBER and CDRH regulations and processes.
- Extensive knowledge of US regulatory requirements for pharmaceutical development and companion diagnostic devices. Background in cell and gene therapy products is highly recommended.
- Experience in submissions and interaction with approval boards (i.e. IRBs, gene therapy committees etc.).
- Master’s degree in Life Sciences or related field. Advanced degree preferred.
Other Skills and Abilities
- Ability to make sound decisions and approach problems with curiosity and open-mindedness.
- High degree of independent working, analytical reasoning and the ability to communicate effectively.
- Careful editing and documenting of results.
- Ability to embrace rapidly changing requirements with an open mind and show a high degree of flexibility in an environment which is marked by a constant striving for excellence.
- Dedication to innovation and science.
- Ability to approach tasks in a structured, reliable and foresighted manner; combined with a high level of individual responsibility, enthusiasm and strong social skills.