Regulatory Affairs Pharmacist
4 weeks ago
Emporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.
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, 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 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 and internal stakeholders
- Formulate or implement regulatory affairs systems, policies, and procedures to ensure regulatory compliance
- Support activities such as internal audits or regulatory agency inspections
- Bachelor's degree in Pharmacy or Diploma in Pharmacy and Registration with the South African Pharmacy Council
- 3 to 5 years of 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
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