Senior Global Program Regulatory Manager

Senior Global Program Regulatory Manager

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do 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.

This role offers hybrid working, requiring 3 days a week / 12 days a month based in office.

As 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 and 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 leads 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 a 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 – preparation of selected global regulatory submissions.
• Portfolio Transformation – e.g. streamlining activities, divestment/integration, portfolio transformation, and manufacturing transfer.
• Business & Operational Excellence – collating, for example, registration samples, CPPs, etc. to support submissions.

NB: if the Senior Global Program Regulatory Manager acts as a Team Lead, manage several direct reports.

Your Experience

• Science-based bachelor's or advanced degree, plus advanced understanding of pharmaceutical development, clinical trials.
• Awareness of post-marketing/brand optimization strategy, with a 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-functional teams.
• Compliance and Quality mindset.
• Fluency in English.