Deputy Manager, Regulatory Affairs

The Regulatory Affairs Deputy Manager is responsible for leading and overseeing the compilation of regulatory dossiers for injectable products targeting the US and European markets. The role requires hands-on experience with 505(b)(2) applications, expertise in regulatory strategy finalization, and proficiency in deficiency response writing. The ideal candidate will possess a strong understanding of FDA guidance, ICH standards, and public domain regulatory information, coupled with effective communication and cross-functional leadership skills.