Senior Regulatory Affairs Pharmacist: Pain, Derma & Digestive (PDD) - POS24205
Area : Midrand
Salary R950 R1m
Qualifications
- Bachelors 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.
Key Job Outputs
- 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 MRAs 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 regulators 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
Closing Date: 25 July 2024
