International Regulatory Affairs Pharmacist (Jhb)
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Job Location:
Cape Town - South Africa
Monthly Salary:
Not Disclosed
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
Introduction
Join a dynamic pharmaceutical company as an International Regulatory Affairs Pharmacist where youll play a pivotal role in ensuring compliance supporting product launches and maintaining regulatory excellence across diverse markets.
Key Responsibilities
- Provide training and peer review of regulatory documents.
- Collaborate with business development on regulatory requirements for dossier acquisition.
- Monitor legislative changes and trends impacting regulatory affairs and product marketability.
- Maintain regulatory documentation filing systems and ensure quality records are retained.
- Implement review and update SOPs to ensure compliance.
- Approve master batch documentation prior to production.
- Liaise with marketing to facilitate timely product launches.
- Approve printed packaging material and promotional marketing material in line with regulatory standards.
- Maintain and update dossiers PI/PIL documents and ensure compliance with current legislation.
- Prepare and respond to SAHPRA Committee recommendations pre- and post-registration.
- Manage new product applications and compile post-registration amendments to ensure dossier compliance.
Minimum Requirements
- Education: Bachelor of Pharmacy Degree.
- Experience: Minimum 2 years regulatory affairs experience in regulated regions (South Africa Europe UK Australia Canada Japan).
- Technical Skills: Docubridge Sage Smartsheet Sweet Process Microsoft Office Suite. ( Preferable experience)
- Behavioural Qualities: Ownership integrity confidentiality ethics leadership communication organisation planning follow-up attention to detail assertiveness patience co-operation and deadline-driven.
- Desirable: Additional years of regulatory affairs experience and proven attention to detail
Collaboration
You will work closely with:
- New Business Development
- Marketing
- Procurement
- Responsible Pharmacist
Working Conditions
- Office-based in Johannesburg with remote options for SA InternationalTravel may be required to SAHPRA and supplier sites.
Dont delay! Click on the link or send your CV today. response
Required Experience:
IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
