Regulatory Affairs Coordinator - COE

Job description

Provide compliant and “ready to submit” dossiers to countries in charge, through the coordination of activities required for new registration, renewal, labeling changes and post approval changes submissions, according to submission plans and Maintenance Committees program. Focal point for the region for the labelling topics when applicable. Coordinate elaboration of dispatch and submission plans with countries in charge

Responsabilities

·  Coordinate activities required for dossier elaboration, evaluation and dispatch of products from relevant BUs to the countries in charge, ensuring compliance with local regulations and accomplishing timing needs
·  Elaboration and/or review of dossiers containing all documents according the legislation (ie, (CMC documents and Administrative docs: GMP, PoA, trademarks certificates, etc, Clinical/ non clinical, BE as needed, PV docs, local forms, IPPs, supportive documents, Artworks, Samples).
·  Coordinate the submission of the revised dossiers in accordance with the legislation of the corresponding countries, ensuring timely dispatch of dossiers to countries in charge.
·  Ensure Risk Assessments of the dossiers before dispatch, including technical viability.
·  Coordinate the elaboration of dispatch and submission plans with countries in charge.
·  Coordinate the communication with Development, RSO, Labeling and Global CMC, Operation
·  Develop and maintain update the knowledge of the legislation of the countries in charge.
·  Ensure a complete dossier for submission, identifying possible requirements that may be done by Heath Authority, in order to avoid processing times increase.
·  Assist all relevant country and region committees to be aligned with Development/Industrial/Quality and Commercial area in decision regarding the products in the market (e.g. Maintenance and Life Cycle Management Committees; Change Contro Committees (BR) to be aligned with variations under process and ensure submission plan and decisions of technical discussions, and GRA Labeling, CMC and Ops);
·  Give regulatory support in Quality by Design meetings for new developments;
·  Keep track of submissions/renewals and variations (including annual reports and PATE, in case of Brazil), sent to the region.
·  Coordinate the answer of deficiency letters originated by Health Authorities of the countries in charge (review information, coordinate times of response).
·  Inform the manufacturing site changes on regulation of the countries that could impact the products
·  Make follow-up and stablish prioritization to the RSO/Global CMC team in preparation of Dossier.
·  Elaborate monthly reports of regulatory movements in the countries in charge.
·  Provide accurate and timely information to maintain regulatory data base of the team updated.
·  Keep requirements and Regulatory Affairs Portfolio databases updated.
·  Coordinate the translation of the dossiers when required according the local legislation
·  Gap Analysis of internal and external dossiers (import and tech transfer), for technical viability and elaboration of risk assessment for submissions in Latin America countries.
·  Evaluation of Local, Regional and Global Change Controls
·  Participation in internal meetings and external meetings for training;
·  Support to DMF analysis for new registration/inclusion of second source and coordination of the projects to be analysed;
·  Optimization of ways of working, ensuring continuous improvement of regulatory tools.
·  Ensure in-time submission of labelling updates.
·  Establish submission strategies leading to compliance with deadlines for labelling updates.
·  Ensure that any variation with labelling impact is appropriately managed and submitted.
·  Strive for the optimization of submissions, especially when multiple variations can be submitted as one.
·  Act as focal point for the region for the labelling topics when applicable.

Qualifications

·  Education: Pharmaceutical Chemical Professional
·  Experience and knowledge: minimum three years in Regulatory Affairs area, stability, analytical validations or quality control in Pharmaceutical Industry.

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