Sr. Director – Regulatory Strategy

Sr. Director – Regulatory Strategy

Requirements

• BS/BA degree in life sciences or related field and 15+ years of experience in Pharmaceutical industry, including drug development experience with demonstrated success in regulatory authority submission strategy, execution and health authority interaction. Prior US marketing application filing experience preferred; Ex-US experience strongly preferred. Experience in writing and leading regulatory documents (e.g., meeting requests/briefing book activities) OR
• Master’s degree in life sciences or related field and 13+ years of related experience OR
• PhD in life sciences or related field and 10+ years of related experience
• Extensive previous managerial experiences also required

Responsibilities

• Responsible for the regulatory leadership of one or more development projects, including responsibility for global regulatory strategy, IND/CTA/NDA/MAA submission preparation, application maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies
• Authoring and oversight of various submission documents, meeting requests, briefing documents; coordination and preparation of teams for health authority meetings
• Oversees the development and implementation of regulatory strategies to ensure the earliest possible marketing approvals by global regulatory authorities
• Accountable for the strategic oversight on global regulatory requirements to management and project teams on all regulatory issues for the strategic development, planning, compilation and submission of IND/CTA and NDA/MAA, ensuring effective integration of global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
• For commercial products, provides regulatory guidance on all aspects of lifecycle management including strategic label development, safety label changes and regulatory management of the product
• Serve as the primary designated program regulatory health authority contact and/or oversees designated health authority contacts. Represents Neurocrine by facilitating interactions with regulatory agencies during all stages of development, registration and commercialization
• Lead the global regulatory subteam for assigned projects and oversee development of dossier filing plan and associated regulatory activity timelines
• Responsible for critical review of all documentation supporting regulatory applications; effectively ensure compliance with internal data standards and regulatory authority submission requirements
• Counsels and advises senior management on status of regulatory strategies and tactics, procedures and practices
• Addresses complex issues, providing advanced regulatory solutions and guidance to cross-functional teams
• Actively partner with key stakeholder groups to define science-based regulatory decision making
• Acts as strategic regulatory liaison with partner companies
• Conducts due diligence activities as a regulatory expert for assigned projects
• Leads continuous improvement efforts on existing department processes and strategies, providing recommendations in area of expertise
• Other duties as assigned

Preferred Qualifications

• Prior US marketing application filing experience preferred
• Ex-US experience strongly preferred