Major Accountabilities:

Regulatory Strategy

• Provide input to global program regulatory strategy, including regulatory designations & innovative approaches and may provide global RA leadership for 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 clinic trails, and the implementation of defined global registration strategy into regional submissions worldwide with country organsiations.
• 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 bachelors or advanced degree, plus advance understanding of pharmaceutical development, clinical trails.
• 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.