Regulatory Affairs Pharmacist

SUMMARY:
Our client, a large manufacturing company, seeks an experienced Pharmacy who can supply a reliable and efficient regulatory affairs service, that puts current regulatory and compliance knowledge of their products to work in attaining the business goals in the manufacture and sale of safe, quality, efficacious products, in accordance with the relevant operational requirements and international accepted regulatory standards.

POSITION INFO:
Minimum Job Requirements:

• Bachelor’s Degree in Pharmacy (non-neg).
• Medicines registration and CTD/e-CTD training.
• Min. 3 years’ 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.

• 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.