Johannesburg North-Gauteng
We are looking for the Head of Regulatory Affairs to join our clients team of experts, a leader who has managed people for a minimum of 5 years. Someone who will oversee the development and delivery of a fully integrated regulatory strategy for the business. In this role, you will also provide compliance advisory with the relevant authorities, guidance and support to the business units and relevant stakeholders.
As one of the leaders in the Pharmaceutical industry, our client strives to add value to the lives of people. When you join their team of experts you will be playing a pivotal role in critical issues facing healthcare today by being given the unique opportunity to innovate, develop and implement value-adding strategies.
A B. Pharm Degree and registration with the South African Pharmacy Council is required. A minimum of 8 years of pharmaceutical regulatory experience an absolute prerequisite
Key outputs include:
- Drive the regulatory process to ensure timely filing of new products and variations following business and compliance objectives.
- Adopt a risk-based assessment for all regulatory submissions and anticipate potential issues for risk mitigation strategies to be in place.
- Anticipate future regulatory changes and impacts on business success.
- Communicate to ensure an excellent understanding of Regulatory Affairs.
- Pays strict attention to detail and accurately monitors and measures progress towards objectives and provides feedback on results whilst maintaining a sense of urgency
- Represent RA at operational meetings such as Technical Transfer, QA, Operations, Launch, Artwork/Packaging, Stability and Research and development, where proactive input can then enhance operational efficiency.
- Assist the launch team to facilitate a smooth launch process in line with product and dossier compliance; to manage all the RA aspects of a launch concerning the product launch plan,
- To give information and input to Responsible Pharmacists to facilitate appropriate decision-making to ensure that all SAHPRA requirements are timeously met.
- Manage the regulatory and compliance aspects of any project launched into operations including acquisitions and mergers, as well as technical transfer projects.
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