Global Program Regulatory Manager (GPRM) (m/f)

Description

• Responsible for implementing regulatory strategy and managing operational activities for assigned regions
• Provide input for global regulatory strategy and contribute to Regulatory Functional Plan (RFP) and Seed Document or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions
• Implement RFP across assigned regions
• Work with Drug Reg. Affairs Global Program Team representative and/or GTAL to plan and facilitate presentations to the clients' regulatory boards on regulatory strategy
• Coordinate and implement regulatory readiness with other line functions, country pharma organisations and key opinion leaders
• Coordinate and plan rehearsals for HA meetings
• Serve as local HA liaison, depending on location (e.g. FDA or EMA)
• Submissions and approvals
• Contribute to the development of the Development Core Data Sheet (DCDS) and Core Data
• Revise labels as needed to achieve timely HA approval with best possible label, based on available data

• Advanced degree (MD, PhD, PharmD) preferred
• Fluency in English as a business language, additional language is of advantage
• Experience with regulatory submission and approval processes in one or more major regions
• Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry
• Experience in HA negotiations
• Profound involvement experience in regulatory and drug/biologic development spanning activities in phases I-IV in the areas of innovation in regulatory strategy, understanding of post-marketing/brand optimisation strategies and commercial awareness preferred
• Involvement in dossier submissions and approvals, HA negotiations, drug regulatory submission and commercialisation
• Strong interpersonal, communication, negotiation and problem solving skills
• Basic organisational awareness (e.g. interrelationship of departments, business priorities)