This position will be responsible for leading the development and implementation of a consolidated (global) regulatory strategy to secure and maintain market access for the assigned product through all development phases and through post-approval life-cycle management. The VP of Global Regulatory Affairs is also responsible for establishing and maintaining effective relationships with regulatory agencies, especially the FDA.
* Anticipates global regulatory changes and develops proactive strategy accordingly. * Develops regulatory strategies which will creatively position innovative products for expeditious review and approval at regulatory agencies. * Review and approve regulatory submission documents and health authority communications. * Interacts with regulatory agencies and ensures conversations and communications are focused, amicable and documented. * Counsel and advise senior management / CMO on status of global regulatory affairs strategies and tactics, procedures and practices and provides critical risk assessments of the strategic alternatives for regulatory filings. * Ensures compliance of regulatory strategies and submissions with current regulations and guidance. * Assess project plans and timelines and ensures all projects are appropriately prioritized and key goals are met on time. * Work to influence regulatory environment through active participation in conferences and industry / agency regulatory meetings, committees and trade associations. * Develop and grow the regulatory department in keeping with the needs of the company, and coach and mentor department staff.
* Collaboration & Teamwork: Advanced competence in collaboration & teamwork, communications influence, strategic agility, planning & organizing, driving results, and problem solving. * Productivity/Organizing/Planning: Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously. * Communication/Presentation Skills: Excellent ability to convey both written and verbal information effectively and efficiently and present information to all levels of audiences. * Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback. * Leadership: Strong ability to establish and communicate clear visioning that team members willingly follow; provide information, knowledge and methods to realize that vision; coordinate and balance conflicting internal and external interests; ability to influence decision-making in a diplomatic manner. Able to navigate team smoothly through difficult situations. * Strategic Thinking: Capable of thinking conceptually, imaginatively, systematically, and opportunistically to achieve company goals.
Education, Prior Work Experience, and Specialized Skills and Knowledge:
* Doctorate, Master's, or Bachelor's degree in a life science field (Biology, Chemistry, or Pharmaceutical sciences) with required years of experience. * A minimum of 10 years Regulatory Affairs experience within small molecule or biologic drug development and registration activities. * Successful submission, approval, and post-approval management of an NDA/MAA/NDS in multiple ICH regions. * Full functional knowledge of regulatory requirements (Directives, Regulations, and Guidance) pertaining to the development and registration of drug products in multiple ICH regions.