Description:
Hire Resolve is seeking a Senior Regulatory Affairs Pharmacist to join our client's team. As a Senior Regulatory Affairs Pharmacist, you will be responsible for ensuring compliance with regulatory requirements and managing the registration of pharmaceutical products.
Responsibilities
- Prepare and submit regulatory applications for the registration of pharmaceutical products
- Review and analyze regulatory documentation for accuracy and completeness
- Develop and maintain relationships with regulatory authorities
- Stay updated on changes in regulatory requirements and guidelines
- Provide regulatory guidance and support to cross-functional teams
- Ensure compliance with relevant regulations and standards
- Participate in regulatory audits and inspections
- Manage the maintenance and renewal of product registrations
- Provide training on regulatory compliance and best practices
- Conduct regulatory impact assessments for product changes and updates
- Collaborate with global regulatory teams on international registration projects
- B. Pharm (Bachelor of Pharmacy)
- Registration with the South African Pharmacy Council (SAPC)
- Minimum 5 years’ experience in Regulatory Affairs (must have experience with human medicine and biologicals)
- Experience in product registration (NCE)
- Maintenance of dossiers and updates
- Pharmacovigilance experience/knowledge of collecting and reporting
- Knowledge of SAHPRA submission portals
- Launch procedures for new products
- Knowledge and experience regarding QA processes, APQRs, customer complaints, etc.
- In-depth knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa related to dossier submissions and lifecycle management
- Knowledge of the Marketing Code
- Systems knowledge
- Competent and experienced in eCTD submissions
- Proficiency in Microsoft Office suite including Word, Excel, and PowerPoint at an Intermediate level
- Familiarity with ZAZIBONA processes
Contact Hire Resolve for your next career-changing move.
- Salary: negotiable.
- Our client is offering a highly competitive salary for this role based on experience.
- Apply for this role today, contact Miné Roux at Hire Resolve or on LinkedIn
- You can also visit the Hire Resolve website: hireresolve.us or email us your CV: manufacturing@hireresolve.za.com
- Alternatively, apply via our portal and email 6A5CE3AF62@jobs.workablemail.com
We will contact you telephonically in 3 days should you be suitable for this vacancy. If you are not suitable, we will put your CV on file and contact you regarding any future vacancies that arise.
Requirements:
Hire Resolve is seeking a Senior Regulatory Affairs Pharmacist to join our client's team. As a Senior Regulatory Affairs Pharmacist, you will be responsible for ensuring compliance with regulatory requirements and managing the registration of pharmaceutical products.
Responsibilities
- Prepare and submit regulatory applications for the registration of pharmaceutical products
- Review and analyze regulatory documentation for accuracy and completeness
- Develop and maintain relationships with regulatory authorities
- Stay updated on changes in regulatory requirements and guidelines
- Provide regulatory guidance and support to cross-functional teams
- Ensure compliance with relevant regulations and standards
- Participate in regulatory audits and inspections
- Manage the maintenance and renewal of product registrations
- Provide training on regulatory compliance and best practices
- Conduct regulatory impact assessments for product changes and updates
- Collaborate with global regulatory teams on international registration projects
- B. Pharm (Bachelor of Pharmacy)
- Registration with the South African Pharmacy Council (SAPC)
- Minimum 5 years’ experience in Regulatory Affairs (must have experience with human medicine and biologicals)
- Experience in product registration (NCE)
- Maintenance of dossiers and updates
- Pharmacovigilance experience/knowledge of collecting and reporting
- Knowledge of SAHPRA submission portals
- Launch procedures for new products
- Knowledge and experience regarding QA processes, APQRs, customer complaints, etc.
- In-depth knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa related to dossier submissions and lifecycle management
- Knowledge of the Marketing Code
- Systems knowledge
- Competent and experienced in eCTD submissions
- Proficiency in Microsoft Office suite including Word, Excel, and PowerPoint at an Intermediate level
- Familiarity with ZAZIBONA processes
Contact Hire Resolve for your next career-changing move.
- Salary: negotiable.
- Our client is offering a highly competitive salary for this role based on experience.
- Apply for this role today, contact Miné Roux at Hire Resolve or on LinkedIn
- You can also visit the Hire Resolve website: hireresolve.us or email us your CV: manufacturing@hireresolve.za.com
- Alternatively, apply via our portal and email 6A5CE3AF62@jobs.workablemail.com
We will contact you telephonically in 3 days should you be suitable for this vacancy. If you are not suitable, we will put your CV on file and contact you regarding any future vacancies that arise.
- Prepare and submit regulatory applications for the registration of pharmaceutical products
- Review and analyze regulatory documentation for accuracy and completeness
- Develop and maintain relationships with regulatory authorities
- Stay updated on changes in regulatory requirements and guidelines
- Provide regulatory guidance and support to cross-functional teams
- Ensure compliance with relevant regulations and standards
- Participate in regulatory audits and inspections
- Manage the maintenance and renewal of product registrations
- Provide training on regulatory compliance and best practices
- Conduct regulatory impact assessments for product changes and updates
- Collaborate with global regulatory teams on international registration projects
- B. Pharm (Bachelor of Pharmacy)
- Registration with the South African Pharmacy Council (SAPC)
- Minimum 5 years’ experience in Regulatory Affairs (must have experience with human medicine and biologicals)
- Experience in product registration (NCE)
- Maintenance of dossiers and updates
- Pharmacovigilance experience/knowledge of collecting and reporting
- Knowledge of SAHPRA submission portals
- Launch procedures for new products
- Knowledge and experience regarding QA processes, APQRs, customer complaints, etc.
- In-depth knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa related to dossier submissions and lifecycle management
- Knowledge of the Marketing Code
- Systems knowledge
- Competent and experienced in eCTD submissions
- Proficiency in Microsoft Office suite including Word, Excel, and PowerPoint at an Intermediate level
- Familiarity with ZAZIBONA processes
- Salary: negotiable.
- Our client is offering a highly competitive salary for this role based on experience.
- Apply for this role today, contact Miné Roux at Hire Resolve or on LinkedIn
- You can also visit the Hire Resolve website: hireresolve.us or email us your CV: manufacturing@hireresolve.za.com
- Alternatively, apply via our portal and email 6A5CE3AF62@jobs.workablemail.com
09 May 2024;
from:
careers24.com