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

• Develop regulatory CMC strategy and plans for Health Authority (HA) interactions as appropriate.
• With moderate guidance, lead CMC preparation activities and represent RA CMC in Health Authority meetings on CMC-related matters
• Contribute to and review HA responses, as required, to ensure appropriate, consistent, and complete answers to any HA CMC questions. Ensure responses are in line with development strategy.
• With moderate guidance, communicate and negotiate with Health Authorities, directly and indirectly

Submissions and Approvals

• Plan and execute regulatory CMC submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities.
• Lead the US submission planning process, including potential Advisory Committees, throughout project lifecycle. This includes oversight of submission plan, generation and sign-off of key regulatory/response components.
• As a CMC product leader or team member, independently define and prepare high quality CMC regulatory submissions in accordance with regulations to ensure completeness and regulatory compliance for filing requirements for assigned compounds throughout development and the commercial life cycle.
• Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall development plan and develop mitigation/contingency plans to increase the probability of an optimal and timely submission and approval.
• Evaluate proposals for variations and amendments change and exercise good judgment in
• Communicate regulatory requirements to product development teams and provide clarity on regulatory expectations and timelines.

Prescribing Information

• Contribute to the development of the first Core Data Sheet (CDS) with input from China affiliates.
• Responsible for ensuring necessary updates or required reviews for the CDS in conjunction with other team members.
• Accountable in conjunction with RA team members for maintaining the CDS though product life cycle.

Regional Excellence and Compliance

• Provide support as needed for regional activities such as Clinical Trial Applications

Managerial

• Serve as role model embracing Systimmune Values and Behaviors. Lead by example.
• Foster constructive working relationships when working with all colleagues.

Qualifications

• Education (Minimum/desirable): Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) is highly preferred.
• Languages: Excellent written and oral communication skills. Fluency in English as a business language. Additional language (Chinese) is an asset.
• Experience:
  • 10 years of pharmaceutical regulatory CMC drug/biologic development experience, ideally spanning activities in Phases I-IV, including experience as an RA CMC product lead, or equivalent industry experience.
  • Experience providing CMC regulatory guidance to drug development, registration, and post-market support teams.
  • Innovation in regulatory CMC strategy.
    • Major involvement in IND/NDA/BLA submission and approval.
    • Leadership role in HA negotiations.
    • Regulatory operational expertise.
  • Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality.
  • Good management, interpersonal, communication, negotiation, and problem-solving skills.
  • Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams.

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.

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