Manager/Senior Manager Regulatory Strategy

Redmond, Washington

SystImmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA. 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 several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.

Summary:

The Senior Director Regulatory Affairs is a Regulatory Affairs strategy leader, supporting all development programs. Functions independently with minimal supervision as a core member of development programs to define and implement US regulatory strategy for the development, submission, approval, and life cycle management of the project(s) in close collaboration with the China team, as appropriate. Responsible for leading a high functioning global regulatory sub team(s) for the program. May also have full regulatory responsibility for one or more early projects with little or no RA sub-team support as appropriate.

Essential Duties and Responsibilities:

Regulatory Strategy

Provide regulatory leadership to assigned project(s).
Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans.
Partner with China team to align on regulatory strategy to fulfill business objectives.
Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall development plan and develop mitigation/contingency plans for identified risks.
Contribute to the development and implementation of the Regulatory Functional Plan.
Obtain timely consultation with RA line management and lead interactions with regulatory consultants/ advisors as appropriate for strategic input on regulatory strategy.
Represent RA on project teams and communicate key program information to regulatory team members and RA management.
Provide strategic input to key HA documents, obtaining appropriate line endorsement as appropriate.
Provide strategic input, review, and approve clinical study protocols and protocol amendments.

HA Interactions

Develop global regulatory strategy and plans for Health Authority (HA) interactions as appropriate.
Contribute to and review HA responses, as required, to ensure appropriate, consistent and complete answers to any HA questions. Ensure responses are in line with development strategy.
May lead interaction with HAs during key HA meetings.
Provide leadership by supporting other line functions in their direct interactions with HAs as appropriate.

Submissions and Approvals

Lead the US submission planning process, including potential Advisory Committees.
Lead regulatory submission process throughout project lifecycle. This includes oversight of submission plan, generation and sign-off of key regulatory/response components.
Proactively address issues, gaps, options and trade-offs for the development plan to increase the probability of an optimal and timely submission and approval.

Prescribing Information

Responsible for developing the first Core Data Sheet (CDS) with input from other RA members, contributing line functions and China affiliates, consistent with development data and objectives of the Target Product Profile (TPP). 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 non-project related regional excellence activities such as Clinical Trial Applications.

Managerial

Effective matrix management of regulatory team(s) consisting of other RA line functions, providing, to the extent possible, mentorship and opportunities for growth and development.
Serve as role model embracing SystImmune Values and Behaviors. Lead by example.

Required Skills & Qualifications:

Education: (Minimum/desirable)

Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred.

Languages:

Fluency in English as a business language. Additional language (Chinese) is an asset.

Experience:

Minimum12 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-IV in most or all of the following areas:
Innovation in regulatory CMC strategy.

Major involvement in IND/NDA/BLA submission and approval.
Leadership role in HA negotiations. Experience in multiple regions is an asset.
Proven success in global drug regulatory submissions.
Proven ability to analyze and interpret efficacy and safety data.

Regulatory operational expertise.
Minimum5 years of demonstrated leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry.
Global matrix management people management experience desirable.
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 stable, well-funded biotech company with a bright future. 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 including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to [email protected]