Job Description

ABOUT ASTRAZENECA

AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the worldxe2x80x99s most serious disease. But wexe2x80x99re more than one of the worldxe2x80x99s leading pharmaceutical companies.

At AstraZeneca wexe2x80x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Therexe2x80x99s 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.

ABOUT OUR SOUTH AFRICA REGULATORY AFFAIRS TEAM

We are passionate about accelerated delivery of innovative medicines thereby ensuring that our patients needs are always put first. We embed Good Regulatory Practice into all our activities thus ensuring compliance is achieved and maintained at all times. Effective stakeholder engagement ensures that we build the right relationships with both our internal and external partners. We continue to grow and challenge ourselves to be the best at what we do.

What youxe2x80x99ll do?

Are you an enabler of access? Do you have a growth mindset? Then we want you to invest in a future at AstraZeneca.

In this role you will work alongside a highly skilled RA team focused on delivering superior quality submissions in an accelerated manner. We continue to embrace new ways of working in a challenging and fast paced healthcare environment where regulations change rapidly. By using clear and logical systems we continue to improve our efficiencies and effectiveness. As a global pharmaceutical company, the pipeline is robust, unequivocal, game changing and thrilling. You will develop strong technical and strategic skills in Oncology, Biopharmaceuticals, Rare Diseases and CVRM. AstraZeneca is a great place to work with an advanced culture of learning and development and Inclusion and Diversity. We will continue to push the boundaries of science and look forward to working with you on our team.

Typical accountabilities will include:

Supports the International Regulatory Affairs Manager in leading the delivery of timely submissions of business priorities in compliance with relevant AstraZeneca procedures and local market regulations.

Contributes to the strategy, direction and efficient operations of the global submissions skill group by continuously enhancing the submissions organization and operating model.

Ensures Regulatory business needs are incorporated within AstraZeneca regulatory systems by being involved in developing requirements, processes, and standards, validating and implementing them and supporting new systems and system enhancements.

Support or lead in regulatory business projects that enhance the portfolio growth, ensure sustainability and improve compliance.

Ensure own work is compliant with all relevant AstraZeneca policies and SAHPRA guidelines.

Proactively collect necessary information from global project teams and plan all submissions management related activities.

Share experiences and contribute to establishing best practices.

Involvement in new product launches with artwork creation and maintenance.

Must have an established working relationship with SAHPRA.

Must be responsible for keeping up to date with latest guidelines from SAHPRA.

If this sounds appealing, please read on to understand the experience and skills wexe2x80x99re looking forxe2x80xa6

ESSENTIAL SKILLS & EXPERIENCE REQUIRED?

Essential

Bachelor of Pharmacy degree. Registered Pharmacist with the SAPC is essential.

5 years or more experience in the Regulatory Affairs environment.

Prior pharmaceutical industry experience.

Experience in regulatory affairs working with SAHPRAxe2x80x99s new guidance.

Project and process management.

Desirable

Experience of working on cross-functional teams.

Knowledge of the drug development processes.

Why AstraZeneca?

At AstraZeneca wexe2x80x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Therexe2x80x99s 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. Wexe2x80x99re 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. Therexe2x80x99s no better place to feel inspired and energized.

SO, WHATxe2x80x99S NEXT?

Are you already imagining yourself joining our team? Good, because we canxe2x80x99t wait to hear from you!

Click the link to apply no later than 05 September 2023 and wexe2x80x99ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn

Follow AstraZeneca on Facebook

Date Posted 30-Aug-2023

Closing Date 05-Sept-2023

AstraZeneca 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.

AstraZeneca