Regulatory Affairs Pharmacist

2 weeks ago


Parktown North, Gauteng, South Africa The Perfect Placements Full time

Our client, a leading company in the pharmaceuticals industry is looking for qualified, career-driven, motivated, passionate, results-driven, team player, analytical and resilient Regulatory Affairs Pharmacist.

-
This position will be based at their head office in Parktown, Gauteng_

Key Performance Areas:

  • 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 ongoing 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.
  • Training and peer review of documents

Skills and Competencies:

  • Docubridge
  • Sage
  • Smartsheet
  • Sweet process
  • Microsoft: Excel, Word, PowerPoint, Outlook
  • Takes ownership and is assertive
  • Integrity, bound to principles, confidentiality, and ethics.
  • Strong leadership skills.
  • Good communication and organisational skills.
  • Good planning and follow up skills.
  • Attention to detail
  • Conscientious.
  • Patient and Cooperative.
  • Deadline Driven

Education and Experience:

  • Bachelor of Pharmacy Degree
  • 2 Years' experience in regulatory affairs
  • Minimum 2 years' experience in regulatory affairs in any regulated regions e.g., South Africa, Europe, UK, Australia, Canada, Japan

Travel:

  • SAHPRA
  • Suppliers

Salary:

  • R R80 000pm based on experience
If you think you are the perfect fit, please submit a head and shoulders picture along with your updated CV

Salary:

R60, R80,000.00 per month

Ability to commute/relocate:

  • Parktown, Gauteng: Reliably commute or planning to relocate before starting work (preferred)

Education:

  • Bachelors (required)

Experience:

Regulatory Affair Regions: 2 years (required)
Regulatory Affairs: 2 years (required)

Willingness to travel:

  • 50% (preferred)


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