Sr Manager - Regulatory Affairs

Sr Manager - Regulatory Affairs
Synowledge PV Services India Pvt Ltd - Bangalore, Karnataka

Seeking a highly motivated Regulatory Affairs Senior Associate/Manager to be responsible for managing the regulatory aspects of our development programs, including the preparation and submission of documents to regulatory agencies. This position will be responsible for providing regulatory guidance and oversight for compounds at various stages of development. Responsibilities include providing regulatory leadership to multidisciplinary project teams, and management of submissions and associated timelines. Responsibilities Coordinate and prepare regulatory submissions to health authorities including FDA, EMA and other national authorities to support clinical trials Coordination and preparation of all regulatory submissions including INDs/CTAs, annual reports, study protocols, study reports, investigator brochures, new investigator information, IMPDs, safety reports, etc. Provide regulatory support to the clinical study teams (review clinical protocols, informed consent forms, Investigators Brochures, and site documentation) Monitor regulatory requirements to assure programs are in compliance with applicable regulations and standards Develop and maintain regulatory knowledge of US, EU and ROW regulations Coordinate and prepare responses to requests for information from health authorities Serve as a liaison with FDA and other regulatory agencies, in coordination with regional regulatory representatives (internal or CRO) on a global basis. Represent the RA function on assigned crossfunctional clinical study teams Manage external vendors and CROs Provide analyses of regulatory guidance documents, regulations, or directives that impact Regulatory Affairs CMC and advice personnel in other departments regarding their applicability. Assess regulatory impact on site and process related changes in change control management system. For more info visit at mentioned link