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

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"