Regulatory Affairs Pharmacist

MAIN PURPOSE OF JOB

• Medicines Registration and Maintenance of Product Licenses with various Health Authorities in African countries

RESPONSIBILITIES

• Responsible for new product applications.
• Compilation and submission of Post –Registration amendments to ensure dossier compliance.
• Responsible for pre and post registration SAHPRA Committee recommendation responses to ensure product registration.
• Responsible for dossier updates, PI/PIL updates to ensure compliance with current legislation
• To ensure approval and compliance of printed packaging material and promotional marketing material.
• Liaising with marketing department to facilitate timeous launch of products.
• Approval of master batch documentation prior to product production.
• Responsible for SOP implementation/review, update and compliance.
• Managing and maintaining regulatory documentation filing system.
• Ensuring regulatory compliance and quality related records are available and retained.
• Ensure on-going regulatory compliance of the existing product portfolio.
• Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of company products
• Liaise with business development for regulatory requirements prior to dossier acquisition.

QUALIFICATIONS & EXPERIENCE

• B. Pharm Degree
• Minimum 2 years’ experience in regulatory affairs in any regulated regions e.g., South Africa Europe, UK, Australia, Canada, Japan

SKILLS/PHYSICAL COMPETENCIES

• Docubridge
• Sage
• Smartsheet
• Sweet process
• Microsoft:
  Excel, Word, PowerPoint, Outlook

BEHAVIOURAL QUALITIES

• Takes ownership.
• Integrity, bound to principles, confidentiality, and ethics.
• Strong leadership skills.
• Good communication skills.
• Good organisational skills.
• Good planning skills.
• Good follow-up skills
• Attention to detail
• Assertive.
• Conscientious.
• Patient.
• Co-operative.
• Deadline Driven