Head of Regulatory Affairs, African Cluster at AstraZeneca

What you’ll do?

• Provides strategic and operational regulatory leadership to the development, commercialisation and life cycle management of the assigned product(s) in product teams. Applies knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies. Influences Regulatory authorities through regular contacts to improve Regulatory outcomes.  Responsible for the management of a skill group such as CMC, Regulatory affairs project management, etc.  Responsible for skill development, performance management, and resource allocation.

Typical Accountabilities

• Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative development issues and 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 AZ RA 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 licenses 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 an appropriate knowledge of quality and compliance
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration
• If this sounds appealing, please read on to understand the experience and skills we’re looking for…..

Essential Skills and Experience Required 

• Qualifications: B. Pharm Degree Registration with South African Pharmacy Council, MS or PhD in life sciences or related field is required.
• A minimum of 8 years of pharmaceutical regulatory experience is a prerequisite with excellent knowledge and understanding of the current pharmaceutical industry
• Minimum of 5 years in people or team leadership is required
• This role requires a high degree of networking & collaboration both within and outside the organization in Africa.
• To ensure legal compliance with the relevant Health Regulatory Authorities (Country Specific where applicable in Africa), Medicines and Related Substances Control Act 101 of 1965, as amended and South African Pharmacy Act (Act 53 of 1974), and other relevant regulations in Africa.
• Experience with regulatory authorities in sub-Saharan Africa and French Speaking Africa will be advantageous
• Significant experience of regulatory drug development, manufacture, commercialisation or equivalent.
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenance
• Proven successful leadership and project management experience.
• Fosters an environment that inspires and empowers the team.
• Proficiency in communication is essential for effectively presenting scientific and strategic concepts, whether through spoken or written mediums
• Demonstrated experience in elevating the capabilities of the organization for now and the future.
• 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