Director, Regulatory CMC (Bilingual in English and Mandarin)

Director Regulatory CMC

The Director Regulatory CMC supports development programs. Functions independently with minimal supervision as a core member of development programs to define and implement US CMC strategy for the development, submission, approval, and life cycle management of the project(s) in close collaboration with the China team, as appropriate.

Responsibilities

Regulatory CMC

• Develop and lead the execution of regulatory CMC investigational, registration, and post-approval strategies for assigned products.
• Work with Process Development and Global CMC team members throughout clinical development and commercial lifecycle to align on regulatory CMC strategy to fulfill business objectives.
• Obtain timely consultation with RA line management and lead interactions with regulatory consultants / advisors as appropriate for strategic input on regulatory CMC strategy.
• Contribute to development of the Regulatory Functional Plan.
• Demonstrate leadership, problem-solving ability, attention to detail, flexibility, and values teamwork.
• Ensure project team colleagues, line management, and partners are informed of developments that may affect regulatory success.

HA Interactions

Submissions and Approvals

Prescribing Information

Regional Excellence and Compliance

Managerial

Qualifications

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.

We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package.