Regulatory Affairs Pharmacist and Deputy

2 weeks ago

Johannesburg, South Africa AstraZeneca Full time

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. 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’ll do?**

With your Pharmacist background and Regulatory expertise and experience, your main focus areas will include:
**Registration planning and business support**
- Implement a registration plan and provide business support.
- Provide regular feedback to the RA Manager and cross functional team and marketing teams on the regulatory submission progress of specific products and ensure support needed to drive performance in their respective departments.
- Robust mitigation plans in place to engage.
- Regulatory authorities when earliest signs of delay emerge. Proactively identify issues and manage risk, taking appropriate action as required on regulatory submission and identify and drive ongoing improvements.
- Quantity and Quality
- Achievements of timely submission and approvals in line with the registration business plan.
- Timeous, comprehensive, and accurate feedback to cross
- functional teams.
- Registration plan
- Implemented and aligned with AZ international priorities and local brand marketing strategy.
- On-going proactive identification and action of opportunities and issues.

**Good Regulatory Practice (GRP)**
- Ensure that all the regulatory processes are performed timeously and in line with GRP.
- Maintain GRP standards in the following process areas:

- Marketing Authorization Applications
- License maintenance e.g., Renewals
- Pharmacovigilance e.g., LRMP
- Labelling and Artwork Management
- Robust Health Authority interactions
- To track and manage all GRP activities and report any non-compliances to the Responsible Pharmacist.
- Complete training in line with the training matrix relevant to job profile.
- Marketing Authorization Applications: Submit Marketing Authorization Applications to the SA Health Authority according to SA HA guidelines and GRP, in the shortest possible time based on business priorities.
- License maintenance: Ensure all post-approval product maintenance activities including CMC variations, package insert safety updates, new indications, technical changes to the label or the packs, PBRERs, and post approval commitments are submitted and approved. Ensure all dossiers are converted in line with legislative requirements.
- Submissions compilation and dispatch: Complete due diligence of registration dossiers/ documents. Obtain relevant information from global RA and resolve queries as they arise to ensure delivery of submissions within agreed timelines.
- Labelling & Artwork Management: Ensure labelling and artworks are effectively managed through the AstraZeneca. Global Labelling Business Process using the GAZELLE system. Co-ordinate the operations of Gazelle through cross-functional departments.
- Health Authority interactions: All communication with Health Authorities regarding submissions, product registration or maintenance throughout the lifecycle of the product is managed effectively.
- Quantity and Quality
- 100 % completion of training as stipulated in the training matrix.
- Review of the Quality Manual and its processes for accuracy.
- Review of registration status & market specific information for accuracy and completeness in the relevant global
- databases (ERV).
- Number of submissions in line with registration plan.
- Time to register new products vs. target and vs. industry norm.
- Extent of compliance of subm

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