Regulatory Affairs Pharmacist (POS24336)
Aeroton Jhb South
R 800 000 per month
Purpose:
Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio outputs. To ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications.
Requirements
- Bachelors degree in Pharmacy and registered with the South African Pharmacy Council
- 1-2 years experience in Regulatory Affairs, preferably in orthodox, human medicines
- Demonstrable experience across the product development, commercialization, and life-cycle maintenance.
- Sound project management capabilities
- Proven ability to consistently deliver to quality, time and cost standards
- Knowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
- Experience in use of CTD software builder and compilation of eCTD application will be an advantage such as docuBridge.
Duties:
- Ensure timeous initiation and management of the registration process for new product submissions
- Ensure approval of registration applications of all medicines with the relevant authorities
- Completes specific pre-registration activities including receipt, screening, compilation and timeous submission of dossier/s Regulatory Authority
- Ensures that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly in order to enable registrations
- Ensures that required standards, protocols and processes around obtaining dossiers and gathering supporting data from suppliers are followed after signing of appropriate agreements
- Ensure the maintenance/ update of registrations in accordance with the relevant legislation, regulations and guidelines
- Receives, prepares and submits all applicable updates, variations, resolutions and any other correspondence required by the Regulatory Authority
- Completes dossier audits of Registered Products for the assigned products
- Conducts dossier due-diligences, post-registration variations for all applicable Regulatory Authorities in compliance with the latest regulatory guidelines and applicable Regulations within the specified time-lines in order to support the business and strategic company objectives
- Establish and maintain effective relationships with Regulatory Authorities
- Manages relationships with the Regulatory Authorities to ensure more effective streamlining of the companys applications when required
- Building sustainable relationships with internal and external stakeholders to achieve regulatory goals
- Effectively managing, auditing and implementation of Regulatory systems
- Prepare, review and adhere to Standard Operating Procedures (SOPs) and local Regulatory Guidelines
- Ensure alignment of personal and company values
To apply for this position, please use POS 24336 RA Pharmacist as reference.
