Job Description

Do you have expertise in and a passion for science and innovation through medicine, working in Regulatory Affairs leading a regulatory team to long-term success, and creating value for our patients through timeous submissions, accelerated approval and regulatory authority relationship and capability building? If so, AstraZeneca might be the one for you!ABOUT ASTRAZENECAAstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines for some of the worlds most serious diseases. But were more than one of the worlds leading pharmaceutical companies. At AstraZeneca, were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development. Our strategic priorities reflect how we are working to deliver our strategy and achieve our Purpose. As a workforce, we are the catalyst for our values: we are entrepreneurial; we do the right thing; we play to win; we put patients first and we follow the science. As a company we appreciate and take great pride in each team member where every person is brought together through shared values, that underpins a shared purpose. Theres no better place to feel inspired and energized.At AstraZeneca, were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Join the fastest-growing pharmaceutical in our markets, set up to fuel further growth. Be part of our shared ambition and pride: our strong heritage, our turnaround story, and early investment and commitment in International markets. Theres no better place to feel inspired and energized.ABOUT OUR REGULATORY AFFAIRS TEAMThe Regulatory Team is a team driven by high performance and a product portfolio growth mindset. The team prides itself in being a team that has well-demonstrated resilience, tenacity to achieve success, a winning attitude, quality submissions, robust systems, accelerated approvals, efficient collaboration and communication, to do the right thing and to execute with excellence and to deliver impactful results. Patient centricity is the driving force behind every interaction the team undertakes. Life-long learning and continuous coaching are part of our make-up. We have a bold ambition to be market leaders in all therapeutic areas across all territories in our regions. A high-performance culture is embedded and entrenched across all teams, enterprise matrix and collaborations are part of our everyday working at AstraZeneca, ensuring that it is through a unified approach that we can achieve more.What youll 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 AccountabilitiesProvides 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 areaRepresents AZRA on relevant external Trade Association committees to ensure AZ RA and/or AZ views on key issues are knownEnsures adequate risk assessments and mitigation plans are included in the regulatory strategy documentsContribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrationsEnsures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activitiesParticipates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/projectEnsures 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 complianceHas personal responsibility for creating a culture of courageous leadership, creativity and collaborationIf this sounds appealing, please read on to understand the experience and skills were looking for..Essential Skills and Experience RequiredQualifications: 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 industryMinimum of 5 years in people or team leadership is requiredThis 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 advantageousSignificant experience of regulatory drug development, manufacture, commercialisation or equivalent.Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenanceProven 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 mediumsDemonstrated 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 authorityKnowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenanceWhy AstraZeneca?We are proud to have achieved Top Employer certification in South Africa, Kenya, and Nigeria, as well as our Best Place To Work certification in Cote d'Ivoire, Cameroon, and Senegal. It is the fourth year South Africa and Kenya have been awarded the Top Employer certification. Amongst the world's top 30 workplaces in 2023 This distinction is a confirmation of our commitment and ability to sustain people, partnerships, and employee engagement and foster an innovative workplace environment.At AstraZeneca, were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. Were on an exciting journey to pioneer the future of healthcare. Join the fastest-growing pharmaceutical in our markets, set up to fuel further growth. Be part of our shared ambition and pride: our strong heritage, our turnaround story, and early investment and commitment in International markets. Theres no better place to feel inspired and energized.SO, WHATS NEXT?Are you already imagining yourself joining our team? Good, because we cant wait to hear from you!Click the link to apply no later than 16 August 2024 and well be in touch as soon as we can.WHERE CAN I FIND OUT MORE?Our Social Media, Follow AstraZeneca on LinkedInFollow AstraZeneca on FacebookClose Date: 16 /08/2024Date Posted 19-Jul-2024Closing Date 15-Aug-2024AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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