Vice President Regulatory Affairs
The VP of Regulatory Affairs is an integral part of Cyteir’s Leadership Team and reports directly to the CEO with oversight of Regulatory Affairs and Quality (GXP). This role is the senior regulatory strategist supporting the early to late phase clinical assets globally. He/she is responsible for developing and implementing regulatory strategy of therapeutic cancer drugs and companion diagnostics leading to successful registration and life-cycle management of all products in all regions. The VP of Regulatory Affairs will provide regulatory leadership through cross functional collaboration, the development, planning and execution of regulatory strategy to facilitate achievement of the company’s short and long-term objectives. The VP of Regulatory Affairs will lead all interactions with regulatory agencies from Pre-IND meeting to pre-NDA meeting and label negotiations.
- Provide regulatory oversight and guidance to project teams to assure all health authority requirements are met and registration is successful using expedited approval processes
- Accountable for the development and submission of regulatory documents (e.g., pre-IND and end of phase briefing books, INDs, IDEs, NDA/BLAs, CTAs, MAAs, responses to regulatory inquiries, annual reports, safety updates, etc.)
- Facilitate problem-solving and drive the overall regulatory strategy with project teams based upon the preclinical, clinical, and CMC development
- Work pro-actively to partner with other functions to plan and execute an effective regulatory strategy in alignment with the overall clinical plan
- Ongoing management of the regulatory strategy including effectively communicating with project teams and external partners to meet timelines for business-critical deliverables
- Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the project teams and Executive Leadership team as required
- Establishes and maintains excellent relationships with regulatory agency personnel. Responds to request for additional data, organizes and manages meetings with global health authorities, and prepares internal teams for these interactions. Negotiates directly with regulatory authorities regarding company filings
- Evaluates and pursues aggressive regulatory options that will lead to successful regulatory approval using expedited pathways
- Oversee or outsource regulatory operations to assure timely publishing of all regulatory submissions
- Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact
- Oversee GX processes and compliance in the company
- Build a regulatory and quality organization
Knowledge and Skill Requirements
- Bachelor’s degree in a scientific discipline; PharmD or PhD preferred
- Minimum 10 years in Regulatory strategy managing oncology programs in the life sciences industry; QA experience is preferred
- Knowledge of the current US, EU and Japanese regulations
- Experience with CTD format and content for regulatory filings
- Demonstrated track record in securing oncology product approvals with successful NDA/BLA and or MAA and maintaining a complex portfolio
- Knowledge of and broad experience with regulatory procedures and legislation for drug development product registration, line extension and license maintenance in the EU and the US
- Familiarity with Fast Track, Orphan Drug and Breakthrough designations and application process
- Experience managing complex schedules and priorities in dynamic environments; ability to conform with shifting priorities, demands and timelines through analytical and problem-solving capabilities
- Ability to communicate effectively both orally and in writing, both internally and with external vendors and partners
- Familiar with e-publishing systems for preparing regulatory submission
- Familiarity with GCP required, GMP and GLP preferred
- Exceptional communication and influencing skills, with the ability to inspire confidence and work successfully with varied audiences including industry partners, financial institutions, Board of Directors, fellow management and employees.
- Strong executive presence.
- Entrepreneurial, collaborative, energetic self-starter with strong interpersonal and analytical skills and proven ability to work effectively with a CEO and other senior management as a strategic partner.
- Strong scientific orientation. Ability to establish and maintain credibility with internal and external scientific and business experts. Willing to explore new options with regulators.
- Desire to be part of a team and organization where patient focus, scientific and business excellence are shared values.
- Commitment to be a leader and culture builder.
- Hard working and energetic.