Regulatory Affairs Manager MANOKAM - HR & Management Consultants ..R

Regulatory Affairs Manager
MANOKAM - HR & Management Consultants - Navi Mumbai, Maharashtra

Managing the appropriate regulatory submissions and premarket registration, and interact with health authorities to obtain and maintain product approvals in the US and international Managing activities such as audits, regulatory agency inspections, or product recalls Coordinating formatting efforts for biologics, drug, and device submissions according to FDA and other global health authorities Responsible for coordination preparation of regulatory submissions and strategies Representing regulatory affairs on product development teams, engineering teams, and other product development initiatives Providing regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products Formulating or implementing regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. Creating, review and approve labeling/promotional/advertising materials, and other documents to ensure compliance to the appropriate regulations Implementing QA systems and generate SOPs Maintaining current knowledge of relevant regulations, including proposed and final rules. Investigating product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessaryCLICK HERE TO APPLY