Regulatory Affairs Pharmacist - City Of Johannesburg Metro
Salary Negotiable
City Of Johannesburg Metro,
Gauteng
more than 14 days ago
Our Client within the Medical and Pharmaceutical Industry is seeking a Regulatory Affairs Pharmacist who has Saharan Africa.
Minimum Requirements
BPharm or equivalent degree (this does not need to be a ZA qualification).
- Experience in Regulatory Affairs.
- Proficiency in the Portuguese Language would be an advantage as involvement in translational activities is required.
Job Specification
Proficiency in the Portuguese Language would be an advantage as involvement in translational activities is required.
2. Compilation and submission of new product applications as per the new products timetables as well as associated regulatory activities in order to ensure timeous registration and launch of new products in sub Saharan Africa.
3. Submission of Package Insert updates for registered products to be done within the stipulated time lines in order to ensure that the product package insert contains the most recent safety data and other relevant information.
4. Submission of pharmaceutical variations and dossier renewals for registered products to be done within the stipulated time lines in order to ensure product compliance in line with local regulations.
5. Review and approval of advertising and promotional material to ensure compliance with the country-specific advertising and company requirements for the marketing of health care products.
6. Ensure that the relevant Corporate Databases for the SSA products are updated within the stipulated time lines.
7. Meeting KPI’s for the artwork review and variation tracking database in order to comply with Corporate/Global RA projects in terms of time lines.
8. Participation in new product launches meetings to ensure that all regulatory relevant steps are finalised.
9. Provide regulatory support for all business units, e.g. tender applications, review of documents for the Quality Affairs department etc.
10. Review of regulatory documents received from Corporate RA or third party companies and communication of additional data requirements for SSA.
Job Description abcd
11. Constantly monitors the medicines regulatory environment in SSA by studying guidelines/documents issued by the relevant Health Authorities from time to time.
12. Remains constantly involved with the dynamics of the regulatory affairs environment through active participation in relevant organizations such as SAPRAA and IPASA.
13. Ensures that all relevant SOPs, Procedures, Working Instructions, etc. in one’s electronic learning plan is read before the effective date.
Key Result Areas:
1. Compilation and submission of new product applications as well as associated regulatory activities in order to ensure timeous registration and launch of new products in sub Saharan Africa.
2. Submission of Package Insert updates for registered products within the stipulated time lines in order to ensure that the product package insert contains the most recent safety data and other relevant information.
3. Submission of pharmaceutical variations and dossier renewals for registered products within stipulated time lines in order to ensure product compliance in line with local regulations.
4. Ensure that the relevant Corporate Databases for the SSA products are updated within the stipulated time lines.
5. Meeting KPI’s for the artwork review and variation tracking database in order to comply with Corporate/Global RA projects in terms of time lines.
6. Review and approval of advertising and promotional material to ensure compliance with the local regulations for the Marketing of Health Care Products.
7. Ensure that all relevant SOPs, Procedures, Working Instructions, etc. in the individual LMS learning plan is read before the effective date. The individual compliance target is > 95 %.
Minimum Requirements
BPharm or equivalent degree (this does not need to be a ZA qualification).
- Experience in Regulatory Affairs.
- Proficiency in the Portuguese Language would be an advantage as involvement in translational activities is required.
Job Specification
Proficiency in the Portuguese Language would be an advantage as involvement in translational activities is required.
2. Compilation and submission of new product applications as per the new products timetables as well as associated regulatory activities in order to ensure timeous registration and launch of new products in sub Saharan Africa.
3. Submission of Package Insert updates for registered products to be done within the stipulated time lines in order to ensure that the product package insert contains the most recent safety data and other relevant information.
4. Submission of pharmaceutical variations and dossier renewals for registered products to be done within the stipulated time lines in order to ensure product compliance in line with local regulations.
5. Review and approval of advertising and promotional material to ensure compliance with the country-specific advertising and company requirements for the marketing of health care products.
6. Ensure that the relevant Corporate Databases for the SSA products are updated within the stipulated time lines.
7. Meeting KPI’s for the artwork review and variation tracking database in order to comply with Corporate/Global RA projects in terms of time lines.
8. Participation in new product launches meetings to ensure that all regulatory relevant steps are finalised.
9. Provide regulatory support for all business units, e.g. tender applications, review of documents for the Quality Affairs department etc.
10. Review of regulatory documents received from Corporate RA or third party companies and communication of additional data requirements for SSA.
Job Description abcd
11. Constantly monitors the medicines regulatory environment in SSA by studying guidelines/documents issued by the relevant Health Authorities from time to time.
12. Remains constantly involved with the dynamics of the regulatory affairs environment through active participation in relevant organizations such as SAPRAA and IPASA.
13. Ensures that all relevant SOPs, Procedures, Working Instructions, etc. in one’s electronic learning plan is read before the effective date.
Key Result Areas:
1. Compilation and submission of new product applications as well as associated regulatory activities in order to ensure timeous registration and launch of new products in sub Saharan Africa.
2. Submission of Package Insert updates for registered products within the stipulated time lines in order to ensure that the product package insert contains the most recent safety data and other relevant information.
3. Submission of pharmaceutical variations and dossier renewals for registered products within stipulated time lines in order to ensure product compliance in line with local regulations.
4. Ensure that the relevant Corporate Databases for the SSA products are updated within the stipulated time lines.
5. Meeting KPI’s for the artwork review and variation tracking database in order to comply with Corporate/Global RA projects in terms of time lines.
6. Review and approval of advertising and promotional material to ensure compliance with the local regulations for the Marketing of Health Care Products.
7. Ensure that all relevant SOPs, Procedures, Working Instructions, etc. in the individual LMS learning plan is read before the effective date. The individual compliance target is > 95 %.
Recruiter: CorporateSOS