Global Regulatory Affairs Director

4 days ago

London, Greater London, United Kingdom Novartis Full time
Job Summary

The Novartis team seeks a seasoned Senior Global Program Regulatory Manager to spearhead the development and implementation of global regulatory strategies for pharmaceutical programs. This senior role offers an exciting opportunity to leverage expertise in regulatory affairs to drive business growth and success.

Working closely with the development team and other stakeholders, you will shape the global regulatory strategy, including regulatory designations and innovative approaches. You will lead the planning, preparation, and submission of clinical trials, while ensuring the seamless implementation of the global registration strategy into regional submissions worldwide.

In this dynamic role, you will also oversee regulatory excellence and compliance, maintaining regulatory information in compliance databases and document management systems. You will work collaboratively with country organizations and regions to ensure timely RA input and submission of regulatory compliance and maintenance reports.

Main Responsibilities
Regulatory Strategy and Planning

You will provide input to the global program regulatory strategy, determining requirements, and coordinating activities for health authority interactions. May lead or serve in HA meetings or local HA liaison respectively.

Regulatory Submissions and Operations

Leads planning, preparation, and submission of clinical trials, ensuring the seamless implementation of the global registration strategy into regional submissions worldwide with country organizations.

Regulatory Compliance and Excellence

Ensures timely RA input and submission of regulatory compliance and maintenance reports, maintaining regulatory information in compliance databases and document management systems.

Career Development Opportunities

You may choose to 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 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 Qualifications
  • 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.

$120,000 - $150,000 per year.

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