Senior Global Program Regulatory Manager

Join Our Development Team! Our purpose is to reimagine medicine to improve and extend people’s lives. To achieve this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities—all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together!

Senior Global Program Regulatory Manager

About the Role: This role offers hybrid working, requiring 3 days a week / 12 days a month based in the office. As a Senior Global Program Regulatory Manager, you will work with limited supervision to develop and implement the global regulatory strategy for program(s) through development, registration, and post-approval in the assigned region(s). You may act as the RA program lead on programs of limited complexity. The Senior Global Program Regulatory Manager is also a member of the RA sub-team and may lead or represent RA in regional or cross-functional teams. You may also act as a subject matter expert and/or assume a mentoring role.

Major Accountabilities

Regulatory Strategy

• Provide input to global program regulatory strategy, including regulatory designations & innovative approaches.
• May provide global RA leadership for a specific part of the program or act as lead for a program of limited complexity.
• Coordinates regulatory readiness with other line functions, Country Organizations & Regions, representing RA or leading in regional RA or cross-functional activities providing strategic input into cross-functional deliverables.
• Contributes to the development and maintenance of key documents, determines the requirements, and coordinates the activity for HA interactions.
• May lead or serve in HA meetings or local HA liaison, respectively.

Regulatory Submissions

• Leads planning, preparation, and submission of clinical trials, and the implementation of defined global registration strategy into regional submissions worldwide with country organizations.
• Coordinates, plans, and prepares for submission of initial registrations and post-approval applications, and the preparation, review, and maintenance of local product information as assigned.
• Lead regulatory activities during HA reviews, responding to questions and HA interactions.

Regulatory Excellence & Compliance

• Ensures timely RA input and submission of regulatory compliance and maintenance reports, maintaining regulatory information in compliance databases and document management systems.
• May serve as an RA subject matter expert and assume a mentoring role.

Life Cycle Management

• You may also focus on one of the following key areas of activity:
• Maintenance – review & sign off of selected global regulatory submissions.
• Portfolio Transformation – e.g., streamlining activities, divestment/integration, portfolio transformation and manufacturing transfer.

Your Experience

Required Qualifications:

• Science-based bachelor's or advanced degree, plus advanced understanding of pharmaceutical development, clinical trials.
• Awareness of post-marketing/brand optimization strategy, with track record of involvement in regulatory or pharmaceutical development in Phases I – IV, in multiple geographies.
• Strong interpersonal skills and experience working in a complex, cross-functional organization and leading cross-function teams.
• Compliance and Quality mindset.
• Fluency in English.