Job Description

Complement Recruitment are recruiting for a Regulatory Affairs Pharmacist whom will compile, submit and track the regulatory submissions for our animal health product portfolio and ensure compliance with the related Acts and guidelines of each territory and includes registration, pre-approval and post-approval activities. Monitoring and reviewing project progress on an ongoing basis. Ensuring the timely completion of responsibilities and activities in line with the business goals. This is a permanent position based in Johannesburg, Gauteng.
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Minimum Requirements Qualifications And Skills

• Minimum Grade 12 Certificate.
• B. Pharm Degree
• Pharmacist registered with the South African Pharmacy Council.
• 5 years' experience in a South African pharmaceutical regulatory affairs environment
• Advantage: Biological product submissions across the African region
• Previous Animal Health industry experience would be an advantage
• Ability to drive and travel locally and internationally if required
• Own vehicle

Duties & Responsibilities:

• Evaluation, compilation and submission of accurate new product applications and post registration dossier amendments to SAHPRA and African Regulatory Authorities, in accordance with established and current formats and requirements.
• Maintenance of registration dossiers in compliance with regulatory requirements, including submission of renewals in South Africa and across Africa.
• Submission of labelling updates in line with the timelines and country specific requirements.
• Evaluation of artwork changes and initiation of artwork.
• Review of promotional material in accordance with relevant Promotional and Marketing Codes.
• Liaising with SAHPRA & the Regulatory Authorities in Africa.
• To act as Deputy Responsible Pharmacist in the absence of the Responsible Pharmacist when required.

Key Skills:

• Strong Communication and interpersonal skills.
• Ability to operate as part of a strategic/operational team.
• Comprehensive knowledge of the industry process.
• Strong problem solving and analytical skills.
• MS Suite proficiency

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Vacancy Overview
Experience
5-10 Years
Job Category
Manufacturing, Medical Healthcare, Health Safety Risk, Technical Operations, Management
Education
Matric Certificate, Bachelor Degree
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