- Midrand
- Salary: R75 000.00 - R83 333.00 Per Month
- Job Type: Permanent
- Sectors: Medical Health Fitness & Beauty Pharmaceutical
- Reference: POS24325
Vacancy Details
Employer: Emporium Human Capital
· 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 MRA’s 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, including but not limited to
· Develop regulatory strategies and implementation plans for the preparation and submission of new products, with a focus on complementary
· medicines and medical devices.
· Conduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicines
· and other human medicines.
· Prepare the registration applications for submission to the regulatory authorities
· Work in collaboration with internal and external stakeholders to assess regulator’s submissions requirements
· Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
· for variations (CMC & Labelling), Renewals, Artwork updates etc.
· 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
· Core competencies
· 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
· Must demonstrate responsibility, excellence and collaboration and align with Company values
Candidate Requirements
· Bachelor’s Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council
· +-5 years’ experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory
· activities.
· 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.
2 people have applied for this job. 73 people have viewed this job.
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