Regulatory Affairs Specialist
2 months ago
We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. The successful candidate will be responsible for managing work streams, reporting on assigned portfolios of products, and ensuring regulatory compliance.
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 timelines, accuracy, comprehensiveness, or compliance with regulatory standards
- Coordinate and submit 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 registration applications for submission to regulatory authorities
- Work in collaboration with internal and external stakeholders to assess regulators' 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 is maintained or enhanced
- Support activities such as internal audits or regulatory agency inspections
- Ensure alignment of personal and company values
- Bachelors 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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