Regulatory Affairs Pharmacist
Large pharmaceutical manufacturing facility seeks to employ a Regulatory Affairs Pharmacist. The following applies:
Key Responsibilities:
- 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.
- Ensure that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly in order 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 (SOPs) and local Regulatory Guidelines.
Key Requirements:
- Bachelor’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 use of CTD software builder and compilation of eCTD application will be an advantage such as docuBridge.
- Knowledge 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)
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