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Senior Regulatory affairs pharmacist

3 months ago

Johannesburg, Gauteng, South Africa Curiska Full time

JOB TITLE: Regulatory Affairs Pharmacist

COMPANY: Pharmaceutical Company

DESCRIPTION:
Join our team as a Regulatory Affairs Pharmacist to ensure a smooth product registration process and compliance with all regulations. Your role involves overseeing regulatory documentation, managing safety updates, and maintaining pharmacovigilance requirements.


DUTIES AND RESPONSIBILITIES:

  • Provide strategic direction as the regulatory affairs pharmacist
  • Ensure regulatory documentation meets requirements
  • Contribute to regulatory strategy alignment with business goals
  • Manage safety updates and CMC updates
  • Approve printed material compliance
  • Handle license renewals with regulatory bodies
  • Develop SOPs following global standards
  • Oversee internal and external audits
  • Update dossiers to ensure compliance
  • Manage product complaints and deviations
  • Maintain regulatory documentation filing system
  • Ensure availability of compliance and quality records
  • Coordinate product recalls or market withdrawals
  • Stay updated on domestic and international laws
  • Report ADR to Global Safety and regulatory bodies
  • Support Pharmacovigilance training
  • Respond to Regulatory Authority requests

MINIMUM REQUIREMENTS:

  • Education:
    - B. Pharm (Bachelor of pharmacy)
  • - Registration with the South African Pharmacy Council (SAPC)
  • Job Training and Experience:
    - Minimum 5 years' Regulatory Affairs experience
  • - Experience in Product registration and maintenance of dossiers
  • - Pharmacovigilance knowledge
  • - Familiarity with SAHPRA submission portals
  • - Knowledge of Launch procedures and QA processes
  • - In-depth knowledge of Regulations and Guidelines
  • - Familiarity with the Marketing Code
  • Systems knowledge:
    - Proficiency in Microsoft Office Suite
  • - Experience with eCTD submissions