Regulatory Affairs Manager

Our client, an international pharmaceutical company that is expanding locally, is recruiting for a Regulatory Affairs Manager. Whilst reporting to the Quality Assurance Manager, your duties will include;

• Preparing and submitting the Drug Master File (DMFs) including DCPs to clients and health authorities, respecting timelines all the time
• Handling Deficiency Letters raised by FDA, health authorities and clients
• Assisting clients by preparing the Applicant Parts (Regulatory Dossier), and the access letters for the registration of drugs
• Proposing improvement in the management process within his/her competence (ICH Guidelines, FDA, Law, etc.)
• Handling eCTD software and other e-platform for submission of Regulatory Documents in various Regulatory Agencies
• Ensuring the Regulatory Compliance across the manufacturing site
• Reviewing change controls for their impact on the respective Regulatory submissions
• Interacting with all customers regarding various Regulatory issues related to submission of Applicants Part of Active substance Master Files (ASMFs)
• Preparing and reviewing SOPs related to regulatory affairs

• Previous experience within a Quality / Regulatory role in Pharmaceuticals is required
• Clear proficiency in leading initiatives which impact regulatory decision-making
• Excellent verbal and written communication skills in English

• A diploma / Degree level of education within a scientific field is required