- Johannesburg
- Salary: R75 000.00 - R83 333.00 Per Month
- Job Type: Permanent
- Sectors: Management Pharmaceutical
- Reference: 91225
Vacancy Details
Employer: Hire Resolve
- 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
- Hire Resolve reviews applications daily, so please upload or email through your CV today!
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
Contact Hire Resolve for your next career-changing move.
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.
1 person has applied for this job. 200 people have viewed this job.
About Hire Resolve
Hire Resolve removes the stress of the career search by
understanding you as an individual. We take more than just your qualifications
into account, considering factors like your salary and benefits expectations as
well as your preferred workplace culture to ensure that we find the perfect
opportunities to meet your unique needs.
As a specialist recruitment agency, we focus on the
Engineering, Finance, IT, Mining, Manufacturing, and Logistics industries. Our
team of recruitment consultants is well-versed and highly networked in the
industries in which they operate and are dedicated to ensuring that every
placement is a perfect fit.
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