Snr Regulatory Affairs Pharmacist

4 weeks ago

Johannesburg, South Africa Hire Resolve Full time

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

Requirements

  • 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

Benefits

  • Family Leave (Maternity, Paternity)
  • Paid Time Off (PTO) (if applicable)

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.

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