Regulatory Affairs Specialist

2 months ago


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

Hire Resolve is seeking a seasoned Regulatory Affairs Manager with expertise in Human Medicine and Biologicals to join our client's dynamic team. In this role, you will be responsible for overseeing regulatory submissions and compliance of pharmaceutical products, ensuring adherence to local and international regulations.

Key Responsibilities:
  • Lead and oversee all regulatory affairs activities related to human medicine and biologicals, ensuring compliance with relevant health authority regulations.
  • Develop and implement regulatory strategies to ensure compliance with relevant health authority regulations, including product registrations and license applications.
  • Prepare and submit documentation for regulatory approvals, including product registrations and license applications, and coordinate with regulatory authorities regarding submissions and queries.
  • Review product labeling, advertising materials, and promotional content for compliance with regulations, ensuring ongoing compliance with post-market surveillance requirements and reporting obligations.
  • Provide regulatory training and support to cross-functional teams, conducting regulatory impact assessments for product changes and maintaining product dossiers.
  • Stay current with changes in applicable regulations, guidelines, and industry standards, ensuring the team's knowledge and expertise are up-to-date.
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 finding the best talent for our clients. If you are a motivated and experienced Regulatory Affairs Manager, we encourage you to apply for this exciting opportunity.



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