Regulatory Affairs Specialist
2 weeks ago
Emporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for pharmaceutical products.
Key Responsibilities:- Manage work streams for- and report on the assigned portfolio of products
- Internal product queries from relevant departments
- External product queries from the SAHPRA, other MRAs and third-party stakeholders
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
- Co-ordination and submission of new product applications in South Africa and other applicable territories
- Develop regulatory strategies and implementation plans for the preparation and submission of new products
- Conduct dossier due diligence to ensure all data gaps are addressed
- Prepare the registration applications for submission to the regulatory authorities
- Work in collaboration with internal and external stakeholders to assess regulators submissions requirements
- Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
- Update and maintain databases, trackers and systems for all regulatory related activities
- Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained
- Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry
- Internal training and mentoring of peers when required
- Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
- Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Support activities such as internal audits or regulatory agency inspections
- Ensure alignment of personal and company values
- Experience in use of CTD software builder and compilation of eCTD dossier applications
- IT skills including Microsoft Office
- Ability to prioritise and work to tight deadlines
- Systems and operations analysis
- Basic cost management skills
- Active learning
- Strategic thinking
- Ability to cope with a high degree of complexity and change
- Cross Functional skills: Ability to network, liaise and negotiate with others
- Ability to set standards and objectives and monitor progress
- Complex problem solving and decision-making skills
- Customer relationships
- Development of people
Closing Date: 31 October 2024
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