Dy Manger/Manager/AGM For API Regulatory Affairs Dept (RA)

Job Description

Academic Background and Experience: Academics - M.Sc. in Chemistry Experience 13 to 25 years Key Skills Regulatory Guidelines Knowledge, Documentation, Problem-solving, Strong Communication, Collaboration, Organization Skills Role & responsibilities Review documents from various departments to compile regulatory submissions. Oversee Drug Master Files (DMFs) for submission to regulatory authorities, including updates, amendments, and revisions as required. Draft both the applicant and restricted parts of DMFs to ensure regulatory compliance. Coordinate with cross-functional teams (CFT) to address deficiencies and feedback from regulatory authorities and customers. Conduct CFT meetings to ensure timely responses to regulatory deficiencies and customer inquiries. Provide regulatory guidance to product development teams and attend Technology Transfer Meetings to support compliance. Maintain and update regulatory databases, ensuring accuracy and completeness. Review and approve regulatory submissions and related documents prepared by team members for compliance. Manage change controls and other relevant documents, including approving them in the HOD's absence. Respond promptly to technical queries from regulatory bodies and customers. Interested candidates share their CV to dinesh.baratam@msnlabs.com Please mention subject line "API RA Manager/AGM profile"