Job Description

Fine Chemicals requires the services of three highly competent Regulatory Affairs Scientists to join our Regulatory Affairs Department. The ideal candidates will be responsible for ensuring compliance with regulatory requirements by compiling technical documentation, conducting risk assessments, and supporting manufacturing processes for the Regulatory Affairs Department.Job Requirements:Educational Background: Bachelorxe2x80x99s degree in chemical engineering, Organic Chemistry, Analytical Chemistry, or a related field.Technical Knowledge: Strong understanding of Chemical Engineering principles, Organic and Analytical Chemistry; proficiency in statistical analysis is advantageous.Industry Experience: Minimum of one year of experience in a pharmaceutical, cGMP-compliant, or chemical manufacturing environment. Experience with manufacturing technology transfer projects is advantageous.Documentation & Data Analysis: Demonstrated ability to compile technical documentation, critically evaluate data, and ensure accuracy in regulatory submissions.Software Proficiency: Strong proficiency in MS Office applications (Word, Excel, Outlook, Teams, Access, PowerPoint). Familiarity with Minitab and/or EXTEDO is advantageous.Key Responsibilities:Manufacturing & Cleaning Documentation: Compile and update manufacturing and cleaning instructions in compliance with internal procedures and regulatory standardsTechnology Transfer: Provide the appropriate support to ensure adherence to all established technology transfer timelines.Risk Assessments: Evaluate the potential presence of elemental, genotoxic, and nitrosamine impurities following relevant regulatory guidelines.Process Qualification: Develop and finalize process qualification protocols and reports to maintain industry compliance.Process Evaluation & Improvement: Analyse and report on process performance, recommending enhancements where necessary.Annual Product Quality Reviews: Conduct annual reviews aligned with cGMP standards, identifying adverse trends and potential process improvements.Change Implementation: Implement modifications related to testing and manufacturing processes in accordance with established company procedures.Regulatory Documentation: Compile and update regulatory submissions, including Common Technical Documents for regulatory authorities.Data Management: Maintain and update relevant databases to ensure accurate capturing of Active Pharmaceutical Ingredient (API) data.Personal Attributes:Strong interpersonal, organisational, and systems implementation skills.Exceptional attention to detail and accuracy.Excellent written and verbal communication skills in English, including strong report writing and document reviewing abilities.Ability to manage multiple tasks concurrently.Self-motivated and results-driven.Suitably qualified applicants are invited to submit their CVxe2x80x99s online on or before the specified date. Preference will be given to applicants from designated groups in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.