Senior Director/VP, Regulatory Affairs

Department: Regulatory Affairs

Position Description

The Senior Director/VP Regulatory Affairs will be responsible for providing global regulatory leadership to support the development, registration, and life-cycle management of Modis products; provide leadership and direction for the global regulatory aspects of Modis products, including developing long and short-term planning of regulatory projects that align with the company’s business plan; and develop strategies to ensure effective achievement of regulatory/business objectives.  Externally this individual will interface with outside regulatory agencies, corporate partners and vendors in regards to development, regulatory and registration strategies.  He/she will lead development and implementation of department policies.

Key Responsibilities

  • Provide regulatory leadership in support of the development, registration and life-cycle management of Modis products
  • Provide strategic regulatory direction on programs including the overall regulatory plan, regulatory requirements for clinical studies and marketing approval, development plans and study designs, risk assessments, critical issue management and Health Authority interactions.
  • Ensure the successful implementation and execution of regulatory plans to support product and approval and commercialization
  • Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development programs and marketed product regulatory issues to support corporate goals
  • Builds partnerships with senior leaders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise
  • Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of products
  • Leads generation of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements
  • Maintains awareness of global regulatory environment and assesses impact of changes on business and product development programs. Facilitates interpretation of global regulation
  • Proactively manages critical issues, taking leadership for the regulatory contribution
  • Develops and implements department policies, processes and SOPs
  • Provides regulatory due diligence assessments of new business opportunities as required
  • Manage vendors and build internal team in context of overall company growth  

Job Qualifications

  • BA/BS Degree required in a health/life sciences or related field.  Advanced degree preferred.
  • A minimum of 10 years in the biotechnology or pharmaceutical industry with at least 3 years of leadership experience managing direct reports
  • Extensive experience in Regulatory including IND/CTA, NDA/BLA/MAA, life-cycle management, interactions with Health Authorities, and developing and implementing complex regulatory strategies
  • Excellent operational skills including demonstrated ability in planning, organizing and ability to motivate and lead others
  • Experience in rare/ultra rare drug development
  • Ability to create and manage detailed timelines and /or experience with tracking regulatory activities across disciplines and territories
  • Strong negotiating skills and ability to think creatively and develop creative solutions
  • Strong personal and interpersonal skills, including the ability to relate to and negotiate with others while acting with integrity and credibility to build trust
  • Ability to prioritize and handle multiple projects simultaneously
  • Sense of urgency and perseverance to achieve results