The Regulatory Strategy Senior Manager will be responsible for contributing regional or global regulatory strategy expertise for development programs or marketed products. The Regulatory Strategy Senior Manager will serve as a regional regulatory lead or in some cases may also be a global regulatory lead for development and/or commercial product(s) within the Vertex portfolio. This role requires understanding of regulatory affairs frameworks in Europe and/ or International/ RoW markets and understanding of drug development CMC and supply chain regulations.

Key Responsibilities:

• Leads the development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs functional team
• Contributes to and may lead global regulatory strategy development for certain programs
• Responsible for regulatory communications with local health authority; may independently lead regulatory interactions with the health authority
• Provides guidance to teams on regulatory requirements for development and approval pathways for assigned region including potential for expedited pathways
• Manages the process for preparation submission and approval of regulatory applications within assigned region
• Provides strategic and technical regulatory input for key product development or registration documents
• Ensures compliance of regulatory submissions with current regulations and guidance
• Reviews and evaluates regulatory intelligence and guidance information to continuously inform regulatory strategy in assigned region.

Key Requirements:

• Relevant educational degree
• Knowledge of relevant regulatory frameworks
• Good understanding of drug development and related concepts
• Good understanding of requirements and processes to maintain a product on the market; reporting and surveillance
• Ability to assess and understand complex scientific information regulatory precedent competitive intelligence and regulatory guidelines and make recommendations based on assessment
• Strong problemsolving skills
• Strong written and verbal communication skills to explain difficult information and build alignment
• Ability to work effectively within a team environment
• Ability to plan prioritize and execute work and projects in a systematic and efficient manner.

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Remote Work :

No