Vice President, Regulatory Affairs

Position Overview - Remote Or Houston Based.The VP, Regulatory Affairs will be a team player with a roll‐up‐the‐sleeves, can‐do attitude and will report to the Senior Vice President of Regulatory Affairs and Quality. A highly cross‐functional role, this person will play a lead role in the filing of multiple investigational new drug applications and be part of the transformative shift the company is making as we move from the pre‐clinical stage to accelerated clinical development.Accountabilities and ResponsibilitiesWorking closely with the SVP of Regulatory Affairs to execute regulatory deliverables and implement regulatory strategy and with a high degree of independence in alignment with overall corporate goals and objectivesWork proactively in a cross‐functional organization to partner with various other functions to help execute an effective regulatory strategy in alignment with the overall clinical development plan and portfolio strategyProvide regulatory oversight and guidance to project teams on regulatory compliance matters, FDA and other competent authority requirements, provide regulatory perspective on clinical trial design to ensure ultimately that endpoints support a future regulatory approvalIndependently manage projects and execute as the RA lead, both in an operational and technical role.Lead the planning, preparation and delivery of submissions throughout the product's life cycle, including briefing documents, INDs, CTAs and annual reports.Review critical regulatory communications and evaluate conformance with the regulatory requirements, clarity, and completenessIdentify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risksPrepare the team and lead negotiations with FDA, EMA, and other health agencies. This includes, preparing responses to questions and inquiries from FDA and other health authorities, overseeing the writing of meeting materials, leading the preparation for meetings with regulatory agencies, and ensuring appropriate follow‐up.Oversee and guide regulatory operations across multiple portfolio assets simultaneously, including budget and operational oversight of external vendors, etc.Experience with the drafting and submission of FDA specialty designation applications (ODD/RMAT/PRD) is preferred.Minimum RequirementsEducationBachelor's degree in life sciences with 12+ years of industry experience, predominantly in Regulatory Affairs or consultingMaster's degree in life science or related discipline, PharmD, MD, and/or PhD preferred in life sciencesExperienceSuccessful submissions of multiple INDs, approval, and post‐approval management of NDAs and/or BLAs in the US and other ICH regionsLicenses or CertificationsRAPS certification is preferred, but not required.Knowledge, Skills, And AttributesFull functional knowledge of regulatory requirements (Directives, Regulations, and Guidance) pertaining to the development and registration of drug products in multiple ICH regions;Well‐developed leadership and project management skills, including demonstrated cross‐functional communication, interpersonal and influence management skillsIND/BLA filing experience preferredStrong influencing and negotiation skills combined with excellent oral and written communications skillsExcellent organizational and analytical skills. Detail‐oriented and a great ability to support multiple projects in a timeline‐driven environment.Interest in and/or experience in the following Therapeutic Area preferred: Neurology, Orphan Rare DiseasesAble to work collaborativelyContinuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.Ability to track and measure performance against defined metrics.Self‐starter with high degree of energy, independence, initiative, and self‐motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.#J-18808-Ljbffr