RA Manager

RA Manager Johannesburg North-Gauteng

Our pharmaceutical client urgently requires a Regulatory Affairs (RA) Manager to lead the Regulatory team in delivering exceptional regulatory services to various departments within the company, external partners, and Principals. This critical role involves overseeing and managing portfolio and team outputs to ensure unwavering legal and regulatory compliance with relevant medicine Regulatory Authorities, the Medicines and Related Substances Control Act, and the South African Pharmacy Council. The RA Manager who will report to the Head of RA will be accountable for ensuring the prompt processing of regulatory applications.

Qualifications/Experience:

• Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council.
• Minimum of 5 years experience in Regulatory Affairs, preferably in human medicines.
• Demonstrable experience across the product development, commercialisation, and maintenance lifecycle.
• Sound project management capabilities.
• Proven ability to consistently deliver to quality, time, and cost standards.

Key Job Outputs:

• Manage work streams and report on the assigned group of portfolios.
• Assist with external product queries from the SAHPRA, other MRAs, and third-party stakeholders.
• Review regulatory agency submission materials to ensure timelines, accuracy, comprehensiveness, and compliance with regulatory standards.
• Coordinate and submit new product applications in South Africa and other applicable territories.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Conduct dossier due diligence to ensure all data gaps are addressed.
• Prepare the registration applications for submission to the regulatory authorities.
• Collaborate with internal and external stakeholders to assess regulators' submission requirements.
• Ensure the maintenance and/or update of existing registrations per relevant legislation, regulations, and guidelines.
• Maintain current knowledge of relevant Acts, Regulations, and Guidelines of the pharmaceutical industry.
• Formulate or implement regulatory affairs systems, policies, and procedures to ensure regulatory compliance is maintained or enhanced.
• Manage activities such as internal audits or regulatory agency inspections.
• Experience in the use of CTD software builder and compilation of eCTD applications will be an advantage.

If you meet the qualifications and are excited about this opportunity, please submit your application to join our clients team and contribute to the success of a leading pharmaceutical company.

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