Global Regulatory Affairs Director - Late R&I

Role Summary

Global Regulatory Affairs Director, Late R&I. Provide strategic and operational regulatory leadership to development, commercialization and life cycle management of assigned product(s). Influence regulatory authorities and apply knowledge of local and global regulatory trends to identify future requirements and strategies.

Responsibilities

• Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative development issues; monitors changes in the regulatory environment in nominated region to support and advise relevant functions
• Provides strategic regulatory advice support for product developments regional therapy area
• Represents AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are known
• Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents
• Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations
• Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities
• Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project
• Ensures all markets remain in compliance with product licences maintained and ensuring improvement plans are in place to close compliance gaps; provide support and advice on training and development to ensure all regulatory personnel in markets have knowledge of quality and compliance
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration

Qualifications

• Minimum 6 years of Regulatory experience in the pharmaceutical industry
• Significant experience of regulatory drug development, manufacture, commercialisation or equivalent
• Proven successful leadership and project management experience
• Broad background of experience of working in several groups in regulatory affairs or experience at a health authority
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenance

Desirable

• Significant Regulatory Experience across global projects and regions
• Strong commercial awareness
• Problem solving skills
• Focus on delivery and results
• Excellent strategic influencing and negotiation
• Develops collaborative working relationships