Regulatory Affairs Pharmacist

Large pharmaceutical manufacturing facility seeks to employ a Regulatory Affairs Pharmacist. The following applies:Key ResponsibilitiesEnsure timeous initiation and management of the registration process for new product submissions.Ensure approval of registration applications of all medicines with the relevant authorities.Ensure that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly to enable registrations.Manage relationships with the Regulatory Authorities to ensure more effective streamlining of the company's applications when required.Effectively manage, audit, and implement Regulatory systems.Prepare, review, and adhere to Standard Operating Procedures (SOP's) and local Regulatory Guidelines.Key RequirementsBachelor's degree in Pharmacy and registered with the South African Pharmacy Council.2-5 years' experience in Regulatory Affairs, preferably in orthodox human medicines.Demonstrable experience across product development, commercialization, and life-cycle maintenance.Knowledge of new and emerging Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry.Experience in the use of CTD software builder and compilation of eCTD applications will be an advantage, such as docuBridge.Key CompetenciesKnowledge of the Regulatory requirements for medical products in South Africa and other applicable territories.Project management and leadership skills.Ability to prioritise and work to tight deadlines.Cross-functional skills: Ability to network, liaise, and negotiate with others.(Full role profile available on application)Apply to (Email Address Removed) Subject: MP/AD_RASupporting Documentation RequiredComprehensive CVCopy of Matric CertificateCopy of Pharmacy Degree.Desired Skills2-5 years' experience in Regulatory Affairs, preferably in orthodox human medicines.Desired Qualification Level & AccreditationsDegreeSouth African Pharmacy Council.
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