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FLSA Classification: Exempt/Salary
Schedule: Monday to Friday; 8:00 am to 5:00 pm
Department: Regulatory Affairs - US
Reports to: Director Regulatory Affairs - EU
Supervisory responsibilities: No
Location: 13203 Murphy Rd., Stafford, TX 77477 or Remote
Position Summary/objective:
Immatics is a clinical-stage biopharmaceutical company developing novel immunotherapies against cancer. We combine the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. Our goal is to provide cancer patients with innovative and effective treatments.
We are seeking a highly motivated Associate Director of CMC Regulatory Affairs to join our US team. The successful candidate will be responsible for leading CMC regulatory activities for our innovative immunotherapy products in the US, ensuring compliance with FDA regulations and guidelines. The Associate Director of CMC Regulatory Affairs will work closely with cross-functional teams to ensure timely and successful submissions, approvals, and product launches.
Develop and implement CMC regulatory strategies for immunotherapy products in the US, including but not limited to manufacturing process changes, method establishment and validation, tech transfer etc.
Ensure compliance with FDA regulations and guidelines
Authoring and maintenance of CMC documentation for cellular products’ INDs (Module 2.3 and 3) and EU CTAs (Q-IMPD, GMO documents, labels) in collaboration with international project teams in the U.S. and Europe.
Authoring and support of responses to CMC requests for information by FDA and EU Competent Authorities.
Manage regulatory submissions timelines and ensure timely approvals
Provide guidance to internal teams on CMC regulatory requirements and changes
Supporting preparation of Health Authority meeting requests and meeting packages from regulatory CMC perspective, participate in meetings with regulatory authorities
Processing and regulatory evaluation of change control procedures in the area of CMC
Monitor and assess regulatory landscape and provide recommendations for strategic decision-making
Prepare and present CMC regulatory updates to senior management
Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder.
Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
Pushing - Exerting force upon an object so that the object moves away from the object.
Pulling - Exerting force upon an object so that the object moves toward the force.
Sitting – remaining in a sitting position for at least 50% of the time.
Standing/Walking - remain on one's feet in an upright position at a workstation.
Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.
Travel required: Limited travel required onsite to Immatics Houston, Immatics Germany or meetings with external parties (health authorities, vendors, collaborators)
Required education and experience:
Bachelors degree in a scientific or related field
Minimum of 8 years of CMC regulatory affairs experience in the biotech or pharmaceutical industry for cell and gene therapy products
Strong knowledge of FDA regulations and guidelines related to CMC
Experience with CMC sections of INDs, IMPDs, BLAs, MAAs and other regulatory submissions in the US and EU
Ability to work cross-functionally and collaborate with internal and external stakeholders
Excellent communication and interpersonal skills
Strong project management and organizational skills
Preferred education and experience:
Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medicalconditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.”
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.