Regulatory Affairs

We are seeking a qualified and experienced Senior Officer/Executive to join our Regulatory Affairs Team. The ideal candidate will specialize in preparing, compiling, and reviewing regulatory dossiers in compliance with international standards and regulatory authority requirements, with a focus on South Africa and other country-specific markets.

❖ Roles & Responsibilities:

Dossier Preparation and Review:

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Compile and review high-quality CTD dossiers and variations as per South Africa and other country-specific requirements, including electronic dossier (dB) compilation and publishing.

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Prepare high-quality eCTD dossiers for new submissions, variations, and responses tailored to regulatory requirements.

Agency Communication and Submission:

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Develop and submit quality responses to agency queries within specified timelines.

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Collaborate with South African counterparts and principals to validate and electronically publish regulatory documents.

Documentation and Compliance:

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Review and manage scientific and technical documents, including DMFs, CEPs, and drug product-related documents, ensuring adherence to regulatory requirements.

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Prepare, update, and review product labeling and information.

Cross-functional Collaboration:

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Coordinate with RD&I, manufacturing sites, customers, and principals to gather required documents for dossier compilation.

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Manage notifications and documentation for implementation of amendments.

Regulatory Process Management:

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Ensure documentation practices align with organizational and regulatory standards.

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Maintain organized and accurate records for all regulatory activities.Role & responsibilities

❖ Requirements:

Bachelors or Master’s degree in Pharmacy (B. Pharm or M. Pharm).

Proven experience in regulatory affairs, with a specialization in dossier preparation for South Africa or similar markets.

Proficiency in electronic publishing tools and CTD/eCTD dossier formats.

In-depth understanding of South Africa-specific regulatory guidelines.

Strong organizational, communication, and documentation skills.

Ability to prioritize multiple projects and meet strict deadlines.

Collaborative team player with a proactive and detail-oriented mindset.