Regulatory Affairs Pharmacist

Complement Recruitment; Johannesburg; On-site; ZAR 600 000 - 800 000; Full time

Job summary

A recruitment agency is seeking a Regulatory Affairs Pharmacist in Johannesburg, South Africa, to manage regulatory submissions for animal health products. The role involves ensuring compliance with guidelines, maintaining registration dossiers, and liaising with regulatory authorities. Ideal candidates will have experience in biological product submissions and strong problem-solving skills. This is a permanent position offering an opportunity to work both locally and potentially internationally.

Benefits

Own vehicle required

Travel opportunities local and international

Animal Health industry experience valued

Qualifications

• Experience with biological product submissions in the animal health sector.
• Familiarity with regulatory requirements for product registration and post-registration.
• Proven ability to manage submissions to SAHPRA and other African Regulatory Authorities.

Responsibilities

• Compile and submit regulatory submissions for animal health products.
• Maintain registration dossiers in compliance with regulations.
• Evaluate and update product labelling as per requirements.
• Review promotional material according to marketing codes.
• Act as Deputy Responsible Pharmacist when needed.

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

Job description

Complement Recruitment are recruiting for a Regulatory Affairs Pharmacist who 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.

Advantages

• 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.

Location: Regulatory Affairs Pharmacist Johannesburg • Johannesburg, South Africa