Organizational Overview:

Immunovant is a publicly traded, clinical stage biopharmaceutical company committed to developing innovative therapies for patients living with autoimmune diseases. We are developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of multiple autoimmune diseases that are mediated by pathogenic IgG antibodies. Phase 2 clinical development is ongoing with Phase 3 preparations underway.

The Role:

The (Associate) Director, Regulatory Affairs Operations, will lead Immunovant’s regulatory information and document management strategy and manage publishing and submissions vendors. This is a leadership role in the company, and the ideal candidate is a strategist and strong collaborator who understands the complexities of these systems and is excited about driving and delivering meaningful changes to support our current and future RIM goals.

Key Responsibilities:

  • Accountable and responsible for building and maintaining relationships with Regulatory and functional groups such as Quality (GxP Systems) and IT business partners to ensure effective communication and efficient implementation and maintenance of regulatory technology and information management standards and processes.
  • Works collaboratively with IT, Quality, and other functional business partners in the management of enterprise systems, the development and adherence to data standards, systems roadmap development, platform strategy, system/ solution review, configuration, and validation efforts.
  • Provides leadership and subject matter expertise on Regulatory systems projects.
  • Responsible for the due diligence, risk assessment, implementation oversight, execution, and delivery of Regulatory systems projects (e.g. RIM, publishing/submission, registration/communication/commitment tracking).
  • Responsible for the daily business administration of Regulatory systems (e.g. SharePoint, InSight Publisher/Viewer and Veeva Vault RIM), including (but not limited to) user management, training, issue escalation and resolution and working with IT, QA, and third-party providers.
  • Responsible for business process development (SOPs, work instructions) and training to ensure stakeholder/partner, process and system alignment in compliance with evolving electronic data standards, global regulatory requirements, and submission of structured data.
  • Partner with vendors and/or IT business partners in keeping updated with technology trends and applicability to business needs.
  • Collaborates on technology initiatives and applies leadership skills by working in a global environment with business colleagues across functional teams
  • Manage external systems and publishing vendors.
  • Implement a robust data governance model and support the oversight process. Ensure data availability in a complete, accurate, and timely manner through use of data quality monitoring methods for systems from planning of regulatory activities through Health authority interaction and to country/ regional implementation.
  • Organize and manage platform support activities, define and manage application enhancement process and release management for R&D Vault applications
  • Collaborate with Veeva QA Vault owner on platform-wide changes adoption and coordinate quarterly Vault releases.
  • Assessment of Information Management vendors, oversight of implementation and maintenance in line with global regulations and industry standards, and in collaboration with IT, Quality, Clinical and other functions
  • Oversight of regulatory publishing and submission vendor
  • Development and deployment of training

 

Requirements:

  • Bachelor’s degree in a relevant scientific discipline and/or information technology. Advanced degree preferred
  • 8+ years of biopharmaceutical experience, which includes at least 5 years of direct experience in Regulatory Affairs operations roles
  • Expert in Regulatory Affairs/Operations and extensive hands-on expertise with document and Regulatory Information Management systems (e.g. Veeva Vault, Documentum, Liquent InSight, PleaseReview, Sharepoint, etc.), including assessment, gap analysis, implementation, migration, and maintenance of these systems
  • Knowledge of drug development and experience in the preparation, publishing, and submission of global regulatory dossiers (including IND/CTA/NDA/BLA/MAA), briefing documents, agency queries, and other types of submissions.
  • Expert knowledge of regulations, processes and industry standards that govern regulated systems, records retention and computer validation quality assurance for the management of regulatory-focused content, throughout the product lifecycle stages, SDLC methodologies and CFR Part 11 and Annex 11 compliance.
  • Demonstrated ability to facilitate, lead and manage the establishment of procedures
  • Strategic and analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Strong leadership in working with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations
  • Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences including executive leadership
  • Ability to thrive in a collaborative and fast-paced environment, with project management skills to effectively manage workload and deliverables under pressure.
  • Experience with working with resource providers including document management systems and regulatory publishing/submissions vendors
  • Experience in working closely with IT business partners internally and managing medium to large scale technology projects (e.g. eDMS, eCTD publishing tools, tracking systems, etc.) from start to finish.
  • Experience in managing day-to-day administration of regulated systems.


Specialized knowledge, Licenses, etc.:

  • Results-oriented individuals with a strong work ethic and ability to complete projects with minimal oversight; track record of successful IND, CTA, NDA/BLA, and MAA submissions
  • Knowledge of GxP, ICH, FDA, EMA and other global regulations and guidance
  • Attention-to-detail and an ability to balance analytical and critical-thinking skills to develop data-driven, strategically oriented regulatory proposals and documents
  • Deep and proven expertise with Veeva Vault R&D platform
  • Knowledge of systems validation concepts for applications and robust understanding and practice of change management
  • Excellent technical understanding and proven, hands-on experience in technologies such as SharePoint, eCTD Publishing Tools (InSight Publisher/Viewer), Veeva Vault RIM, and off-the-shelf and plug-in software such and StartingPoint Templates, DXC Toolbox that supports the global Regulatory business and have solid understanding in developing Regulatory requirements.
  • Expert in the use of Microsoft Office Suite (Word, Excel, Power Point, Project, Visio).
  • Commitment to company values and culture
  • Proven ability to adapt to change and uncertainty as projects evolve
  • Strong oral and written communicator
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
  • Ability to multi-task and adjust priorities quickly while working under tight deadlines.
  • Skilled in developing collaborative internal and external relationships.
  • Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Project).


Work Environment:

  • The position will be located in Immunovant’s NY office 
  • Dynamic, interactive, fast-paced, and entrepreneurial environment 
  • Domestic or international travel is required (~10%)

 

This position has been filled.