The role involves handling initial submissions, deficiency management, post-approval variations and lifecycle management activities in compliance with global regulatory requirements.
Seeking a highly experienced Regulatory Affairs professional to manage regulatory activities for parenteral (injectable) products across the LATAM region. The role involves end-to-end regulatory lifecycle management, ensuring timely submissions, approvals, and compliance with regional regulatory requirements.
Preparation and control of SOPs, STPs, specifications, formats, and master documents. Review of BMR, BPR, deviations, change controls, and CAPA records. CLAPS Industries require QA Documentation professional
Postgraduate degree in life sciences, pharmacy, biotechnology, clinical research, regulatory affairs or other relevant discipline from a recognized university, with at least 5 years of relevant experience in project or program management
Plan, track, and deliver submissions aligned with timelines and regulatory requirements. Manage risks, dependencies, and complexities in global regulatory environments.
Experienced Shift In Charge to Manage daily manufacturing Operations, ensuring strict cGMP, Safety and regulatory Compliance. Key duties include production planning & ensuring execution as per plan, preparing batch records and qualification documents.