Regulatory Affairs Pharmacist
Durban, KwaZulu-Natal, South Africa
Job Description
Minimum Job Requirements:
- Bachelorxc3xa2xc2x80xc2x99s Degree in Pharmacy (non-neg).
- Medicines registration and CTD/e-CTD training.
- Min. 3 yearsxc3xa2xc2x80xc2x99 experience in the SA pharmaceutical industry in a manufacturing/quality assurance/regulatory environment.
- Understanding of a pharmaceutical quality system, cGMP, GPP principles and pharmaceutical legal requirements.
- Regulatory experience and skills in compiling, preparing, submitting and maintaining dossiers and new drug applications.
- International regulatory submissions.
- Experience in biological medicines manufacturing industry.
- e-CTD submissions.
- MS Office (Word, Excel, PowerPoint, Outlook).
- SAP proficient.
Report to the RA Manager:
- National product regulatory submissions and applications.
- International product regulatory submissions and registrations.
- Regulatory changes with respect to product licensing conditions, standards and compliance.
- Regulatory Affairs administration.
- Internal and external networking and support.
- SAP proficient.
- MS Office proficiency (Word, Excel, PowerPoint, Outlook).
- Performance management.
- Technical / professional knowledge and skills.
- Leading and influencing others.
- Business impact.
- Planning and organising.
- Attention to detail.
- Communication (written and verbal).
- Critical thinking.
- Analytical/problem-solving skills.
- Initiative and self-motivation.
- Interpersonal skills.
- Teamwork and collaboration.
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Job Detail
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Job IdJD1342287
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationDurban, KwaZulu-Natal, South Africa
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EducationNot mentioned