Click Job Application – Regulatory Pharmacist

Job Description:

Clicks is searching for an individual that is able to work with the current team to ensure that Unicorn Pharmaceuticals remain compliant with all regulatory and legal requirements. To take full responsibility and accountability in managing all the tasks related to dossiers within the guidelines and regulations of the MCC.

Job Responsibilities:

• To evaluate (due diligence), compile, submit, monitor and manage all Unicorn dossiers for complementary and generic medicines and devices in South Africa and neighboring countries.
• To manage transfers of registered dossiers to Unicorn and amendments including PI & PIL, safety updates and API.
• To coordinate with Unicorn suppliers, manufacturers and external regulatory consultants to ensure resolution of issues (MCC queries) and technical matters, maintaining amendment schedules, obtaining master documentation to facilitate compilation, submission and approval by the regulatory authorities (MCC).
• To actively complete CTD conversions as per allocated time table and to ensure product dossiers are maintained and updated on the electronic database and paper copies available for inspection.
• Responsible for reviewing and approving the Unicorn product packaging design process and promotional material by ensuring all elements conform to the Marketing code and MCC guidelines.
• To ensure relevant SOPs are compiled and updated.
• To keep abreast of new pharmaceutical and regulatory trends (dosage forms, active ingredients, regulatory changes) across the industry.
• Any other duties as per changes in operational requirements of the department to deliver Regulatory compliance.

Job Requirements:

• At least 2-5 years working experience in a regulatory and quality assurance environment within the pharmaceutical industry
• B. Pharm Degree, registered with the SA Pharmacy Council and in good standing
• Medicines registration course
• Knowledge of the generic pharmaceutical market
• Knowledge of registrations in South Africa and other African countries
• Pharmaceutical industry laws, regulations and ethics (Medicines and Pharmacy Acts)
• Other Industry related laws, regulations and ethics (CPA, Companies and Competition Acts)
• Medicine Control Council Codes
• Business processes
• Knowledge of Pharmaceutical Manufacturing, Wholesaling/Distribution
• GWP/GDP/GMP
• Project management, planning and organising skills
• Computer literate and able to effectively use Excel and Word and applicable software
• Policy and procedure development skills
• Analytical and problem-solving skills
• Highly accurate and has good attention to detail
• Communication skills, both verbal and effective writing
• People and relationship building skills
• Presentation skills
• Record keeping and documentation skills
• Professional and presentable
• Results driven
• Self-discipline and effective administration skills
• Positive attitude
• Self-motivated

Job Details:

Company: Clicks Group

Vacancy Type:  Full Time

Job Location: Cape Town

Application Deadline: N/A

Apply Here

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