Regulatory Affairs Pharmacist

SUMMARY:
Our client, a large manufacturing company currently seeks the services of a Regulatory Affairs Pharmacist, who will be based in the Quality Management & Scientific Affairs Administration department and report to the Regulatory Affairs Specialist.

POSITION INFO:

Minimum Qualifications and Experience Required:

• Bachelor’s Degree in Pharmacy.
• Medicines registration and CTD/e-CTD training.
• 2 years’ experience in the SA pharmaceutical industry in a manufacturing/quality assurance/regulatory environment.
• MS Office proficiency (Word, Excel, Powerpoint, Outlook).
• Regulatory experience and skills in the compilation, preparation, submission and maintenance of dossiers and new drug applications.
• Understanding of a pharmaceutical quality system, cGMP, GPP principles and pharmaceutical legal requirements.
• International regulatory submissions.
• Experience in biologicals medicines manufacturing industry.
• e-CTD submissions.
• SAP proficient.

Key Performance Areas:

• National product regulatory submissions and applications.
• International product regulatory submissions and registrations.
• Regulatory changes with respect to product licensing condxitions, standards and compliance.
• Regulatory Affairs administration.
• Internal and external networking and support.

Competencies:

• Technical / professional knowledge and skills.
• Planning and organising.
• Attention to detail.
• Communication (written and verbal).
• Critical thinking.
• Analytical/problem solving skills.
• Work standards.
• Initiative and self-motivation.
• Networking and liaison.
• Interpersonal skills.
• Teamwork and collaboration.

 

NB! This job is now closed. You can apply for other jobs by uploading your CV.

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