Regulatory Affairs Pharmacist Sa

6 months ago

Johannesburg, South Africa AstraZeneca Full time

**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 world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s 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 you’ll 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 we’re looking for**

**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 SAHPRA’s new guidance.
- Project and process management.

**Desirable**
- Experience of working on cross-functional teams.
- Knowledge of the drug development processes.

**Why AstraZeneca?**
- At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s 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. We’re 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. There’s no better place to feel inspired and energized._

**SO, WHAT’S NEXT?**

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you

**WHERE CAN I FIND OUT MORE?

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