Global Program Regulatory & Strategy Senior Manager

• Drive the regulatory strategy, planning and execution across key regions for the assigned development pipeline projects (from early pre-clinical phases)
• Collaborate with cross-functional teams to ensure timely submissions, approvals, and compliance with global regulatory requirements, supporting the successful development and registration of innovative pharmaceutical products.

Major Activities

Key Responsibilities

• Develop and implement Global regulatory strategies for assigned pipeline development programs, ensuring alignment with global regulatory requirements and company objectives.
• Provide regulatory input into R&D programs to ensure they meet regulatory expectations
• Prepare, review, and manage regulatory submissions including INDs, NDAs, MAAs, ensuring accuracy, completeness, and timely delivery.
• Coordinate responses to health authority queries, ensuring scientifically sound and compliant answers within required timelines.
• Monitor evolving regulatory requirements across major markets (FDA, EMA, ICH,) and proactively assess their impact on development programs and submission strategies.
• Collaborate with cross-functional teams (R&D, Clinical Development, CMC, Safety, Quality, business etc ) to ensure integrated regulatory plans
• Support regulatory meetings and interactions with health authorities, including briefing document preparation
• Ensure compliance with internal SOPs and global standards, contributing to continuous improvement initiatives and best practices in regulatory operations.
• Review and approve Clinical Trials Applications (CTAs)
• Perform regulatory Due Diligence activities for acquisition of new assets in development stages to enhance Company pipeline

Job Dimensions

Ideal Background

Degree in a scientific field

Languages

Fluent in written and spoken English

Experience/Professional requirement

• More than 5 years of successful managerial experience in the pharmaceutical industry with a proven track record of successful registrations of innovative products in Key Regions (i.e. EU, US, Japan)
• Strong knowledge of regulatory submission and approval processes in Key Regions
• Strong knowledge of Drug development & regulatory processes behind with a focus on early-stage assets
• Experience leading regulatory submissions and approvals of innovative products Key Regions
• Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry
• Experience on project allocation/project planning within a cross-functional team working in matrix organization
• Excellent interpersonal, communication, negotiation and problem-solving skills.
• Organizational awareness (e.g., interrelationship of departments, business priorities).
• Fluency in English as a business language. Excellent written and verbal communication skills.
• Confident, articulate, and professional speaking abilities (and experience). Excellent presentation and negotiation skills.