Regulatory Affairs Specialist
2 months ago
We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.
Key Responsibilities- Manage work streams for- and report on the assigned portfolio of products:
- Assist with internal product queries from relevant departments:
- Assist with external product queries from regulatory authorities and third-party stakeholders:
- Establish regulatory priorities and allocate resources and workloads:
- Review regulatory agency submissions to ensure accuracy, comprehensiveness, and compliance with regulatory standards:
- Coordinate and submit new product applications in South Africa and other applicable territories:
- Develop regulatory strategies and implementation plans for new products:
- Conduct dossier due diligence to ensure all data gaps are addressed:
- Prepare registration applications for submission to regulatory authorities:
- Work with internal and external stakeholders to assess regulator's submission requirements:
- Maintain current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry:
- Internal training and mentoring:
- Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders:
- Formulate or implement regulatory affairs systems, policies, and procedures to ensure regulatory compliance:
- Support activities such as internal audits or regulatory agency inspections:
- Ensure alignment of personal and company values:
- Bachelor's degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council:
- 3 to 5 years' experience in Regulatory Affairs, preferably in human medicines:
- Demonstrable experience across the product development, commercialization, and maintenance lifecycle:
- Sound project management capabilities:
- Proven ability to consistently deliver to quality, time, and cost standards:
- Experience in use of CTD software builder and compilation of eCTD applications:
- IT skills:
- Ability to prioritize 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:
- Must demonstrate responsibility, excellence, and collaboration and align with Company values:
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