Director, Global Regulatory Lead

Essential Areas Of Responsibility

• Designs and implements regulatory strategies to obtain, maintain product investigational and marketing applications, and extend product registrations.
• Singles point of contact and accountability for regulatory and leads the regulatory sub teams as well as represents regulatory on global development teams.
• Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans.
• Identifies and assesses regulatory risks associated with product development for assigned projects.
• Led the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., CTAs, MAAs and other relevant regulatory filings.
• Serves as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.
• Oversee ex-US regulatory representatives and consultants.
• Provides guidance to all appropriate departments to assure compliance with applicable regulations.
• Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel.
• Makes recommendations for regulatory department operating procedures.
• May be involved in participating as the Regulatory reviewer in formal MLR and Promotional Review Board activities.
• May supervise Regulatory Affairs Associates.
• Consistently works with abstract ideas or situations across functional areas of the business.
• Through assessment of intangible variables, identifies and evaluates fundamental issues providing strategy and directions for major functional areas.

Education Minimum Education, Experience and Skill Requirements

• Minimum Education, Experience and Skill Requirements: BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred or equivalent relevant experience.
• Experience: Has 8-15 years of Regulatory Affairs experience. The regulatory experience should be broad (across the life cycle of pharmaceutical products through commercialization and across main regions such as US, EU, Japan, and Canada and other) to ensure appropriate leadership and mentoring for regulatory staff within Rezolute.
• Strong competency in understanding regulatory requirements and emerging regulatory landscape associated with the HA(s).
• Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
• Ability to present complex issues in oral and written form.
• Experienced in responding to inquiries from HAs.