Regulatory Affairs Specialist

1 week ago


Johannesburg, Gauteng, South Africa Hire Resolve Full time
Regulatory Affairs Manager Job Description

Hire Resolve is seeking a seasoned Regulatory Affairs Manager to lead our client's dynamic team in managing regulatory submissions and compliance for human medicine and biologicals.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with local and international regulations.
  • Prepare and submit documentation for regulatory approvals, including product registrations and license applications.
  • Coordinate and liaise with regulatory authorities regarding submissions and queries.
  • Review product labeling, advertising materials, and promotional content for compliance with regulations.
  • Ensure ongoing compliance with post-market surveillance requirements and reporting obligations.
  • Provide regulatory training and support to cross-functional teams.
  • Conduct regulatory impact assessments for product changes and maintain product dossiers.
  • Stay current with changes in applicable regulations, guidelines, and industry standards.
Requirements:
  • B. Pharm (Bachelor of Pharmacy) and registration with the South African Pharmacy Council (SAPC)
  • Minimum 10 years' experience in Regulatory Affairs with human medicine and biologicals experience
  • Skills: product registration and dossier maintenance, pharmacovigilance experience, knowledge of SAHPRA submission portals, launch procedures for new products, QA processes, APQRs, customer complaints, knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa, Microsoft Office Suite proficiency, familiarity with ZAZIBONA processes and eCTD submissions
Benefits:
  • Family Leave (Maternity, Paternity)
  • Paid Time Off (PTO) (if applicable)

Hire Resolve is committed to providing a competitive salary for this role based on experience. If you are a motivated and experienced Regulatory Affairs Manager, please apply today by contacting Miné Roux at Hire Resolve or on LinkedIn. You can also visit the Hire Resolve website or email us your CV. We will contact you telephonically in 3 days should you be suitable for this vacancy.



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