Senior Regulatory Affairs Pharmacist, Bryanston (South Africa)
Do you have expertise in regulatory affairs and passion for seeing the safe and effective use of pharmaceutical medicines for patients? Would you like to apply your expertise to help turn our pipeline into reality? 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.
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. There’s no better place to feel inspired and energised.
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. 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.
ABOUT THE 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. As leaders in the market, we utilize 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 successful and committed to everyday excellence. We have enjoyed a number of successes thus far having achieved a number of approvals on new products and new indications to date. We put the patients 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 will do
Organizes local submission plans on all products for assigned countries that implement the agreed regulatory strategy to register and maintain products. Responsible for submission compilation and approval information processes.
Responsible for the regulatory activities related to product’s life-cycle maintenance. This includes the variations and license renewal. Professional communication with all relevant stakeholders. Support country regulatory lead in the registration activities. Supports local distributor regulatory team in all the activities related to maintenance of products in compliance with all local and global Good Regulatory Practices (GRP). Regulatory Systems updates
Job Description Summary
Organizes local submission plans on all products for assigned countries that implement the agreed regulatory strategy to register and maintain products.
Responsible for submission compilation and approval information processes.
Responsible for the regulatory activities related to product’s life-cycle maintenance. This includes the variations and license renewal.
Professional communication with all relevant stakeholders.
- Support country regulatory lead in the registration activities.
- Supports local distributor regulatory team in all the activities related to maintenance of products in compliance with all local and global Good Regulatory Practices (GRP).
- Regulatory Systems updates
Typical Accountabilities
Supports all activities related to the REGISTRATION and MAINTENANCE of products in compliance with all local and global codes, standards and procedures as well as HA laws and regulations as follows:
- Adequate preparation and compilation of submission dossiers.
- Ensure timely submission of registration dossiers according to the MC plans of submission.
- Obtaining regulatory approvals and ensuring maintenance/variation procedures are effectively in place.
Getting appointments from HA for submissions.
Working with the South African Health Products Regulatory Authority (SAHPRA).
Ensuring administrative validation, chasing up the dossier throughout the assessment and anticipating the possible questions from the Competent Authorities including AdHoc queries in order to optimize the timing, the quality of the answers and the Marketing Authorization (MA) approval and Summary of Product Characteristics (SPC) wording.
Answer Queries from health authorities (HA) in a consistent manner and within the time limits and in any case according to internal guidelines
Obtaining approvals and ensuring maintenance/variation procedures are effectively in place, in a timely manner.
Ensure Implementation of the variations as per HA laws and regulations.
Follow and support the country local distributor and AZ iRAMs in product license maintenance activities and HAQs.
Regulatory support to the Regulatory Country lead in the divestment projects.
Maintenance and Updating of the regulatory Systems as per GRP standards and KPIs.
Tracking of submission/achievements being able to satisfy the requirements of any audit or inspection
Translation of HA communication/approvals, in case needed.
Communicating official regulations and guidelines issued by the HA to the global teams through AZ proper systems.
Cross functional collaboration with the team members and relevant Stakeholders in respect to AZ values and code of ethics.
Has potential for creating a culture of courageous leadership & creativity.
If this sounds appealing, please read on to understand the experience and skills we’re looking for…
Essential Education, Qualifications, Skills and Experience required
Must have a completed B.Pharma Degree or related qualification.
Minimum of 3-7 years proven experience in a pharmaceutical regulatory affairs environment including compilation and submission of variations, application for new products and life cycle maintenance in accordance with the latest regulatory authority requirements.
Registered with the South African Pharmacy Council as a practicing Pharmacist.
Experience in eCTD.
Expertise in Information and document management technology and electronic/paper publishing software.
Excellent written and verbal communication skills.
Thorough knowledge of world-wide Health Authority requirements on Regulatory technical format including processes and technologies.
Expertise in Information and document management technology and electronic/paper publishing software.
To ensure legal compliance with the relevant Health Regulatory Authorities, Medicines, and Related Substances Control Act 101 of 1965, as amended and South African Pharmacy Act (Act 53 of 1974), and other relevant regulations.
Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and license maintenance.
Proven successful project management experience.
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.
Desirable
7 years of regional regulatory experience.
Vault System knowledge.
Precision and accuracy.
Flexibility
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! Click the link to apply no later than 14 March 2025 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: 14/03/2025
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 authorisation and employment eligibility verification requirements.
