Are you a Pharmacist with expertise in Regulatory Affairs working in a Pharmaceutical industry ? If so, AstraZeneca might be the one for you!

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

Across our diverse group of markets we bring transformative products to the market, to ultimately transform the lives of people living with serious diseases. Leaders in the market, we utilise our large data sets and scientific backing, to influence opinion leaders and key stakeholders. Adapting and transforming each unique

healthcare system in our markets.

Our SA Regulatory Affairs team is a successful team committed to everyday excellence.  We have enjoyed a number of successes thus far in 2021 – having achieved a number of approvals on new products and new indications to date.  We put the patient first in every decision we make. Compliance is at the heart of all we do. Collaboration within the team, the wider cross functional team, industry bodies and SAHPRA is key to our success.

What you’ll do?

As the successful candidate you will be at the forefront of innovation by being involved in the registration and maintenance activities for products that help fight diseases in some of the most critical areas of medical need.  You will also interact with leaders in their field who will offer the most insightful product based discussions as you grow from strength to strength in your career. 

With your Pharmacist background and Regulatory expertise and experience, your main focus areas will include:

• Effectively manage and control the registration process for specific products within a therapeutic area.
• Obtaining essential marketing authorizations for AstraZeneca products.
• Management and assurance of regulatory compliance activities.
• Ensuring best practice in line with Good Regulatory Practice, current legislation and standards of ethical and professional performance.
• Implementing registration plan and business support for allocated products
• Implementing GRP standards in line with International Procedure 1-P56-cv-X “Good Regulatory Practice in AstraZeneca” that support license to operate across the Regulatory Value Chain.
• Ensuring that the regulatory processes for allocated products are performed timeously in line with GRP.
• Submitting Marketing Authorization Applications to Health Authorities according to local guidelines and GRP, based on business priorities.
• Ensuring all post approval product maintenance activities including CMC variations, professional information safety updates, new indications, technical changes to the label or the packs, and post approval commitments are submitted and approved
• Completing due diligence of registration documents/dossiers
• Obtaining relevant information from key Global RA and resolve queries timeously to ensure delivery of submissions within agreed timelines
• Ensuring labelling and artworks are effectively managed through AstraZeneca Global Labelling Business Process using GAZELLE system.
• Managing communication with Health Authority regarding submissions, product registration or maintenance throughout the lifecycle of the product.
• Act as Deputy Responsible Pharmacist in the absence of the Responsible Pharmacist ensuring that AstraZeneca Pharmaceuticals (Pty) Ltd is in compliance with Act 101 of 1965 and the Pharmacy Act 53 of 1974.

If this sounds appealing, please read on to understand the experience and skills we’re looking for…

ESSENTIAL SKILLS & EXPERIENCE REQUIRED?

• BPharm with SAPC
• English speaking (must have an understanding of Afrikaans)
• Experience in Regulatory Affairs in the South African environment
• Excellent written and verbal communication skills
• Computer literate
• Good presentation skills
• Strong skills in time management, planning and organization

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 energised.

SO, WHAT’S NEXT?

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

Apply no later than 24 June 2021 and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Close Date: 24/06/2021

Date Posted

Closing Date

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.