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Regulatory Affairs Pharmacist

4 months ago

Johannesburg, South Africa Kumusa Consulting Full time

To ensure legal compliance with the relevant medicine Regulatory Authorities (Country
Specific where applicable), Medicines and Related Substances Control Act and South African

**Required Learning/Experience**
- Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
- Minimum of 1-3 years experience in Regulatory Affairs, preferably in human medicines Demonstrable experience across the product development, commercialization, and maintenance lifecycle
- Experience in baseline creation will be advantageous
- Proven ability to consistently deliver to quality, time, and cost standards

**Key Job Outputs**
- Manage work streams for
- and report on the assigned portfolio
- Assisting with internal product queries from relevant departments
- Assisting with external product queries from the SAHPRA and third-party stakeholders
- Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations, and guidelines
- Knowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry in South Africa and other applicable territories.
- Establish and maintain effective relationships with Regulatory Authorities.
- Building sustainable relationships with internal and external stakeholders to achieve regulatory goals.
- Adhere to Standard Operating Procedures (SOPs); Working Instructions (WI) and applicable Regulatory Guidelines
- Ensure alignment of personal and company values
- Stakeholder management and regulatory intelligence for additional streams such as launch, technical transfer, laboratory validations etc.