Overview
Our client is looking for a Regulatory Affairs Pharmacist. This role is responsible for ensuring that the company's products comply with all applicable regulatory requirements. This includes reviewing and drafting regulatory submissions, providing advice to product development teams, and managing regulatory relationships. The ideal candidate will have a strong understanding of pharmaceutical regulations, as well as excellent communication and analytical skills.
Responibilities: Investigates and interpret the regulatory and legislative needs globally and summarize the requirements as per business needs.
Manages and is responsible for the registration of products and supplements globally by initiating, compiling, approving and submitting the necessary documents to the regulatory body as per requirements.
Maintains the barcodes list by issuing new barcodes on request per template.
Maintains the barcodes list by issuing new barcodes on request per template.
Sources and summaries of regulatory requirements for new territories.
Initiates and actions Change controls on regulatory changes as required.
Prepares and authorizes declarations for AUS shipments.
Prepares and drafts an impact study on raw materials when required to ensure compliance with global regulations.
Ensures international and national legislations are adhered to by reviewing standards versus dossiers as per alert notifications.
Manages the lifecycle of the company product registrations in accordance with Legal and Regulatory requirements.
Ensures that any products registered as pharmaceuticals are sufficiently controlled and that the correct procedures governing these products are implemented.
Requests product information or declarations from R&D and generates as per template, the SDS for finished goods, CITIES, and files SDSs electronically.
Reviews and authorizes SOPs where required e.g., artwork updates, registration process.
Performs annual product reviews as per regulatory standards by trending regulatory information and other relevant information (SAHPRA).
Prepares information needed for Quality Management System’s review meeting by trending regulatory information as per set objectives per department.
Implements identified actions and regulatory requests as per senior management’s evaluation of risk.
Conducts impact assessments on new/updated formulas.
Reports monthly on regulatory updates to Quality Assurance Manager and provides progress reports when requested.
Checks all artwork to ensure regulatory requirements are met globally by using the Brand specification sheets provided.
Manages the External supplier audit schedule and ensures that audits are conducted as per the schedule.
Conducts Internal and Supplier Audits as per the relevant Audit Schedule and follows up on all non-conformances identified.
Governs the External provider approval and monitoring process.
Ensures that findings are resolved by communicating with relevant external providers.
Key Skills: Knowledge of legislation governing cosmetic products and supplements.
Able to synthesize complex information and convert it into a comprehensible manner.
Excellent writing skills.
Excellent communication skills.
Critical thinking.
Reading comprehension.
Time management.
Excellent analytical and presentation skills.
Attention to detail and accuracy.
Work independently
Assertive
Professional
Competent
Qualifications: B. Pharm mandatory
A regulatory Affairs course in cosmetics would be beneficial.
3 years’ experience in a pharmaceutical/cosmetic manufacturing environment in a Regulatory Affairs role.
