Company Jobs

The role involves handling initial submissions, deficiency management, post-approval variations and lifecycle management activities in compliance with global regulatory requirements.

Manage end-to-end recruitment and talent acquisition. Coordinate hiring requirements with plant teams and hiring managers.

Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. 

Experience in solid oral dosage & liquid orals form in formulation & development department for regulated market

Handling QMS as per Regulatory requirements. Handling Deviations, CAPA, Change Controls, OOS investigations. Responsible to process internal quality audits.

Workmen allocation and manpower management on shift basis. Supervision of secondary packing operations, especially bottle lines. Compliance with cGMP, safety, and hygiene requirements.

Exposure to OSD Manufacturing operations like Granulation, Pellet coating, Compression, Coating, Capsules, Primary Packing

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.