Job Roles & Responsibilities in Regulatory Affairs Department
International (RoW Market):
Hands on experience on Preparation and submission of dossiers in CTD format for Asia, Africa, Latin America & CIS regions
Hands on experience on Preparation and submission of dossiers as per ACTD guideline for Asian region
Hands on experience on Preparation and submission of dossiers as per the country specific guidelines for various countries.
Hands on experience on Preparation, review and submission of response to queries from various agencies of various countries
Coordinating with cross-functional departments (FR&D, AR&D, QA, QC and production) for documents required for submission of dossiers and responding queries.
Preparation and filing of Re-registration of products at various countries according to the authorization validity period
Preparing and submission of changes / variations to the dossiers, as Amendments and annual updates for post approval changes of the respective products.
Reviewed documents including clinical study reports, validation and stability protocols and reports.
Reviewed labeling drafts, Patient Information leaflet and final approval in co-ordination with PMT, PD, QA and Medical Services departments.
Preparation, reviewing and advising on SmPCs and packaging
Maintained product core dossier and product master files.
Worked as part of a team dealing with global registrations and provide regulatory support to all operational departments within the company.
Responsible for training and development of the team through setting objectives and performance review processes.
Providing technical review of data or reports that will be incorporated into regulatory submissions to assure scientific on presentation
Maintain the regulatory guidelines from various regulatory authorities
Preparation of CTD dossier as per CDSCO guidelines for New Drug Application in India.
Preparation of Application for renewal of Manufacturing license and WHO GMP certificate, etc.
Preparation and submission of Post Approval Changes (PAC) as per CDSO compliance
Preparation and filing of Variations
Preparation of Applications to obtain certificates like Test License, Free Sale Certificate, COPP etc.
Preparation of application to obtain NOC For Clinical trial batches.
Preparation and Submission of regulatory documents for Tender participation and its approval at domestic level as well as RoW