Intel Corporation is hiring a
Vice President Regulatory Operational Excellence in Worldwide

Summary

The job is for a VP of Regulatory Affairs Operational Excellence in a biopharmaceutical company, Immunovant. The role involves overseeing multiple groups within the Regulatory Affairs department, including Regulatory Operations, Regulatory Business Operations, and Medical Writing. The ideal candidate should have a minimum of 12-15 years regulatory industry experience, be familiar with Veeva, and have experience in managing budgets, clinical trials, regulatory operations, submission management, and regulatory writing.

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
• Demonstrated experience with effective management of direct reports, contractors/consultants, and vendors

Responsibilities

• Manage for 3 to 6 Regulatory personnel, including the Senior Director heads of Regulatory Operations and Medical Writing
• 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

Benefits

• 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