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Senior Regulatory Affairs Pharmacist: OTC
1 month ago
Emporium Human Capital is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs team, you will be responsible for managing work streams, reporting on assigned portfolios of products, and ensuring regulatory compliance.
Key Responsibilities:- Manage work streams for internal and external product queries
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submissions to ensure timelines, accuracy, and compliance
- 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 data gaps are addressed
- Prepare registration applications for submission to regulatory authorities
- Collaborate with internal and external stakeholders to assess regulators' submission requirements
- Ensure maintenance and/or update of existing registrations
- Update and maintain databases, trackers, and systems for regulatory activities
- Comply with Quality Management System requirements to ensure Good Regulatory Practices
- Maintain current knowledge of relevant Acts, Regulations, and Guidelines
- Internal training and mentoring of peers when required
- Establish and maintain effective relationships with Regulatory Authorities and stakeholders
- Formulate or implement regulatory affairs systems, policies, and procedures
- Support activities such as internal audits or regulatory agency inspections
- Bachelors Degree in Pharmacy and Registration with the South African Pharmacy Council
- +-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
- Good Manufacturing Practices (GMP)
- Pharmaceutical production experience or exposure to supplement regulatory knowledge
- Experience in use of CTD software builder and compilation of eCTD dossier applications
- IT skills including Microsoft Office
- 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
Closing Date: 25 July 2024
