Regulatory Affairs Pharmacist

2 weeks ago

Johannesburg, Gauteng, South Africa Servier Full time

Date posted:28 Feb 2024
City:
Johannesburg
Country/Region:ZA
Type of Contract:Permanent
Job Requisition ID:5374Regulatory Affairs Pharmacist
- .
REGULATORY AFFAIRS PHARMACIST

JOB OVERVIEW**:

  • Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain Servier's pharmacovigilance requirements.

DUTIES AND RESPONSIBILITIES:

  • Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist
  • Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications.
  • Provide input to the regulatory strategy inline with business objectives
  • Detailed understanding of regulatory guidelines and technical requirements
  • Manage and implement safety updates where required
  • Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations
  • To ensure approval and compliance of printed packaging material and promotional marketing material.
  • License renewals with service providers i.e. SAHPRA, South African Pharmacy Council (SAPC)
  • Writing and developing of SOP in line with Global SOP's
  • Manage internal and external audits (i.e.
Global & SAHPRA)

  • Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation
  • Manage of product complaints and deviations
  • Managing and maintaining regulatory documentation filing system.
  • Ensuring regulatory compliance and quality related records are available and retained.
  • Coordinate product recall or market withdrawal when necessary
  • Obtain and distribute updated information on domestic and international laws
  • Report ADR to Global Safety and SAHPRA
  • Followup of Adverse Drug Reactions (ADRs),
  • Pharmacovigilance training of local staff
  • Answering of requests from the Regulatory Authority with cooperation with Global Safety
  • MINIMUM REQUIREMENTS:
  • Education:
  • B. Pharm (Bachelor of pharmacy)
  • Registration with the South African Pharmacy Council (SAPC)
  • Job Training and Experience:
  • Minimum 5 years' experience in Regulatory Affairs
  • (must have human medicine experience and biologicals)
  • Experience in Product registration (NCE)
  • Maintenance of dossiers and updating thereof
  • Pharmacovigilance experience/knowledge of collecting and reporting
  • Knowledge of SAHPRA submission portals
  • Launch procedures for new products
  • Knowledgeable and experienced regarding QA processes, APQRs, customer complaints etc.
  • Indepth knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa pertaining to dossier submissions and life cycle management.
  • Knowledge of the Marketing Code
  • Systems knowledge:
  • Microsoft office suite including Word, Excel, Power Point at an Intermediate level.
  • Familiar with ZAZIBONA processes
  • Competent and experienced in eCTD submissions.
  • INDISPENSIBLE QUALITIES:
  • Focus
  • Attention to detail
  • Flexibility
  • Planning and organisation
  • Communication
  • Teamwork
  • Confidentiality
  • Agile and able to work in a fast pace
  • Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailormade onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your wellbeing.
  • At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

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