Vice President – Global Regulatory Affairs

We are seeking a Vice President, Regulatory Affairs, who will be responsible for developing and leading all regulatory strategies and activities for AskBio, including all regulatory submissions. This includes ensuring that all corporate regulatory goals are met and in compliance with all current industry standards globally. This role will manage internal regulatory staff, oversee third-party regulatory service providers, and will be a key member of the senior leadership team.

Responsibilities and Accountabilities

  • Contributes to the development and implementation of pre-clinical, clinical, CMC and regulatory strategies for projects in all stages of development (pre-IND through BLA)
  • Works cross-functionally with internal departments, including clinical, quality, manufacturing and third parties on Regulatory Affairs-related issues
  • Serves as a primary liaison to U.S. FDA, EMA, and other regulatory authorities
  • Defines strategies for, coordinates the execution of, and ensures the proper archival of regulatory submissions including Investigational New Drug (IND) applications, IMPDs, Biologics License Applications (BLA) and Marketing Authorization Approvals (MAAs)
  • Interprets FDA (and other regulatory bodies) communications, expectations and decisions to internal and external stakeholders (including CROs, CMO’s, consultants and contractors), developing and implementing successful issue resolution strategies
  • Develops strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities, including meeting requests, briefing packages, fast track, orphan and RMAT applications/designations
  • Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents across regions
  • Contributes to the creation of the regulatory product strategy and manages the development, monitoring, and delivery of integrated regulatory project plans throughout the product lifecycle
  • Manages the completion of documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes
  • Identifies and assesses regulatory risks of projects or programs
  • Presents operational plans, scientific data and strategy to internal and external audiences, including regulators, key opinion leaders, partners and executives
  • Advises executive and senior management of the impact the changing regulatory environment can/will have on our business and projects
  • Responsible for cost-effective management of the Regulatory Affairs department budget
  • Responsible for departmental resources, including recruitment, deployment, professional development and management of regulatory staff
  • Maintains and creates relevant SOPs, work instructions and other necessary guidance
  • Special projects, as assigned

About you: 

  • Advanced degree with a focus in Pharmaceutical Sciences or a technical field preferred. Will consider minimum BS or an MS degree holder: 20+(BS), 18+(MS), 14+(PhD) years of relevant and current work experience in the fields of Regulatory Affairs, product development, and/or clinical operations
  • 5+ years of demonstrated success in a regulatory team leadership role and proven management by influence
  • Ability to work across diverse geographic and cultural differences within AskBio’s organization
  • Displays the highest standards of personal and professional conduct. Supports organizational ethical standards and values
  • Ability to respond quickly and accurately to requests/inquiries
  • Ability to respectfully interact with all levels of management and departments within AskBio
  • Ability to interpret, communicate and present regulatory information clearly and concisely
  • Proven negotiation skills
  • Extensive knowledge of regulations and regulatory process in all global markets
  • Solid understanding of regulations, regulatory processes and dossier requirements for Biologics License (BLA) Applications, Marketing Authorization Application (MAA) and Clinical Trial Authorization (IND, IMPD, CTA) in global markets
  • Must be able to think strategically and establish business priorities with a longer-term focus based on the organization’s vision
  • Experience with global teams
  • Gene therapy experience highly preferred