Vice President Regulatory Operational Excellence

 

Organizational Overview:

Immunovant is a clinical-stage biopharmaceutical company with a company vision focused on enabling normal lives for patients with autoimmune diseases. Our lead asset, IMVT-1401, is a novel, fully-human, anti-FcRn monoclonal antibody in clinical development for multiple indications, delivered as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. Immunovant is committed to developing innovative therapies that not only treat the symptoms but modify the course of autoimmune diseases, while restoring hope and health to patients with autoimmune disease by developing and delivering high-value restorative therapies that enable them to live normal lives.

 

The Role:

This newly created role within the Regulatory Affairs organization is an exciting opportunity for a seasoned Regulatory Affairs professional to serve as a leader in the oversight and optimization of multiple groups within the Regulatory Affairs department.  The VP of Regulatory Affairs Operational Excellence reports to the Senior Vice President of Regulatory Affairs and will be responsible for overseeing the following Regulatory groups:

• Regulatory Operations
  • Regulatory Operations is responsible for regulatory/submission coordination (incl, development of submission content plans and timelines), regulatory information management and regulatory submissions, business processes related to submission publishing standards and correspondence archival, and Veeva RIM utilization and RIM-SMART.
• Regulatory Business Operations
  • Regulatory Business Operations is responsible for development of best practices for information sharing and document writing, vendor management (including regulatory consultants, subscriptions, and contract medical writers), assessment of new technologies to improve efficiency in end-to-end regulatory support of clinical development programs, and development/assessment of overall regulatory and medical writing department budgets.
• Medical Writing
  • Immunovant Medical Writing is composed of both in-house and contract writers. The team is responsible for development of writing standards and best practices, writing of documents including briefing documents, clinical protocols, CTD modules, investigators brochures, clinical study reports, responses to Health Authority queries, etc.

The ideal candidate will have subject matter knowledge in the above Regulatory arenas. S/He should have a proven track record of managing multiple functions and people with the discretion to appropriately prioritize initiatives and needs of their teams, groups, and individuals in a fast-paced and dynamic environment.  This position will need to have strong relationships across all functions associated with document content writing, management, and retention requirements.  This position will drive operational transformation to accommodate near- and long-term corporate objectives that require Regulatory operational foresight.  S/He will review clinical/regulatory documents to support all phases of drug development by leading MW project management activities of an interdisciplinary team to ensure documents are strategic, high quality, and comply with internal and external standards.  S/He will delegate workplans for ongoing initiatives as appropriate, and provide leadership and strategic support for the team responsible for development and implementation.

 

Key Responsibilities: 

• Manage for 3 to 6 Regulatory personnel, including the Senior Director heads of Regulatory Operations and Medical Writing, who will also have their own direct reports.
• Manage budget for Medical Writing and Regulatory Affairs department
• Manage short term and long term activities and initiatives of Regulatory Operations, Regulatory Business Operations, and Medical Writing while adapting to changing priorities of the company and overall portfolio of programs.
• Development and rollout of document templates and writing standards to ensure compliance with regulations, GxP standards, and other internal/external guidelines.
• Portfolio-level oversight to ensure key content messaging messaging in regulatory/clinical documents across 1401 and 1402 programs.
• Drive organizational improvement by proactively communicating with Regulatory and cross-functional stakeholders to problem-solve and identify appropriate operating models for each of the relevant functions.
• Serve as a conduit of information flow between Regulatory leadership and the functions overseen by this position. Identify opportunities for synergies across the Regulatory organization.
• Present various topics and recommendations to Immunovant executive leadership.
• Ensure teams are tracking towards timely completion of deliverables.
• When necessary, serve as intermediary between vendors in support of Immunovant Regulatory staff.
• Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
• Continually evaluate appropriateness and effectiveness of quality standards, templates, information technology platforms, and processes; identify opportunities for improvements.
• Foster the growth and development and provide mentorship for the Regulatory Affairs team.

 

Requirements:

• Bachelor’s degree in a scientific discipline required; advanced degree highly desired
• Minimum 12-15 years regulatory industry experience in biopharmaceuticals
• Experience with Veeva and implementation of new processes within Veeva
• Experience with management of a budget to facilitate fiscal planning and accountability of spending.
• Hands-on or oversight experience with regulatory support of clinical trials; regulatory operations and submission management; and regulatory writing
• Experience with clinical stage assets required; experience with BLA/MAA and post-marketing strongly preferred
• Highly effective communication skills and confidence to lead strongly when necessary/appropriate
• Ability to pivot comfortably and judiciously communicate change within a rapidly evolving company environment
• Understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies for drug development and approval.
• Strong knowledge of eCTD elements and structure with regulatory writing skills
• Strong knowledge of drug development, FDA, EMA and other guidelines and regulations
• Working knowledge of electronic submission procedures and document management system requirements.
• Working knowledge of regulatory submission management, electronic publishing, and document management. Experience with Veeva systems strongly preferred.
• Experience of filing NDA/BLA/MAA application and meeting submission quality and standards
• Demonstrated experience with effective management of direct reports, contractors/consultants, and vendors.

 

Work Environment:

• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Immunovant’s headquarters is located in New York City. The position will be remote work.
• Domestic travel required (up to 20%)

 

Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $320,000.00 - $340,000.00.

 

 

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