Regulatory Affairs Specialist

Regulatory Affairs SpecialistThis position is responsible for coordinating activities related to compliance with the Regulatory Framework in Mexico, aligned to the needs and strategies defined by the different participating areas of GSK, focused on the submission and approval of administrative and technical modifications.Responsibilities:Know and comply with local and/or corporate, national and/or international laws, policies, and guidelines applicable to the position.Actively participate in projects to improve the area and site.Comply with the training and development plan assigned to the position.Develop regulatory strategies (Third Parties, Demand and Commercial) together with the Regulatory Affairs Manager.Provide local or international contacts with specific requirements of the Mexican market.Coordinate and execute activities related to the preparation and submission to the Ministry of Health in Mexico on:Registration renewals.Variations to registration conditions: change in formula, active ingredient, manufacturing process, packaging, shelf-life extension, line extensions, manufacturing sites, and new indications.Product Information updates.Specific cases such as technical queries, meetings, etc.Responses to Health Authority Questions.Monitoring and response to commitments.Update information in the dossier in accordance with Mexican Regulation.Maintain and update applicable systems (Submission Plan, Veeva, Filestorage, etc).Your Qualifications:Professional background in pharmaceutical chemistry or related field.1 year experience in regulatory affairs or release of biological products.Knowledge of Office package.Intermediate to advanced level of English.Experience in Pharma.If you think this is the next move in YOUR career, apply by June 30, 2024.#J-18808-Ljbffr