Regulatory Affairs Pharmacist at SMArt Recruiting, LLC

Job description

Based in Crown Mines, our client is seeking an RA Pharmacist.

EDUCATION

• Matriculation exemption.
• B.Pharm Degree.

Desirable Skills & Experience

3 years experience in Regulatory Affairs and Production.

Skills/Physical Competencies

Good understanding of Microsoft Office/Outlook

• Company Compliance
• To ensure approval of printed packaging material and promotional marketing material.
• Ensuring compliance with marketing product claims using regulatory expertise.
• Liaising with marketing department to facilitate timeous launch of products.
• Responsible for SOP implementation/review, update and compliance.
• Product Registration
• Liaise with business development for regulatory requirements prior to dossier acquisition.
• Responsible for anticipating, receiving and submission of new product registrations for a particular financial year.
• Responsible for submission of generic dossiers, NCE’s as well as complimentary medicines.
• Ensure on-going regulatory compliance of the existing product portfolio.
• Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of company products.
• Ensuring that the company is aware of significant local regulatory issues which can impact the business.
• Documentation Management
• Managing and maintaining regulatory documentation filing system.
• Ensuring regulatory compliance and quality related records are available and retained.
• MCC Submissions
• Responsible for new product applications.
• Manage Post –Registration amendments to ensure dossier compliance.
• Responsible for Committee recommendation responses to ensure product registration.
• Responsible for dossier updates to ensure compliance with current legislation.
• Pharmacovigilance
• Responsible for Pharmacovigilance monitoring within the group

• Other
• Providing status reports to the regulatory department head on the status of projects currently worked on.

BEHAVIOURAL QUALITIES

• Takes ownership.
• Integrity, bound to principles, confidentiality and ethics.
• Strong leadership skills.