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Regulatory Affairs Specialist

2 months ago


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

Hire Resolve's client is seeking a highly skilled Regulatory Affairs Manager to join their team in Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring seamless product registration and dossier maintenance, while ensuring compliance with all regulations and pharmacovigilance requirements.

Key Responsibilities
  • Develop and execute strategic direction for regulatory affairs.
  • Ensure regulatory documentation meets relevant requirements and specifications.
  • Provide input to regulatory strategy in line with business objectives.
  • Manage safety updates and implement quality management systems.
  • Handle license renewals and manage product complaints.
  • Develop and maintain SOPs and manage internal and external audits.
  • Responsible for updates of dossiers and product information.
  • Ensure regulatory compliance and quality-related records are available.
  • Coordinate product recall or market withdrawal when necessary.
Requirements
  • B. Pharm (Bachelor of Pharmacy) degree.
  • Registration with the South African Pharmacy Council (SAPC).
  • Minimum 10 years' experience in Regulatory Affairs with human medicine and biologicals experience.
  • Product registration and dossier maintenance experience.
  • Pharmacovigilance experience and knowledge of SAHPRA submission portals.
  • Launch procedures for new products.
  • QA processes and customer complaints experience.
  • Knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa.
  • Microsoft Office Suite proficiency.
Benefits

Hire Resolve offers a competitive salary and a dynamic work environment.

Contact Hire Resolve for more information.