.Job title:_ Senior Regulatory Affairs Associate_- _ Location: CDMX_- _ 70% Remote working_- _ Job type: Permanent_- About the job- Our Team:- Elaboration of dossier for LCM variations (CMC, Labeling, Admin) and renewals according to local requirements (all products categories, including Biological and vaccines). Elaboration of HAQ responses according to strategies defined by CRM._- Elaborate and follow up dispatch plan in alignment with affiliate's priorities and established deadlines according to process type._- Generate and propose to the regulatory affiliate regulatory submission strategies for the CMC variations received._- Main responsibilities:- Responsible for CP verification, dossier elaboration and dispatch of products from relevant BUs to the countries in charge, ensuring compliance with local regulations and accomplishing timing needs.- Responsible for the dispatch plan of respective dossiers.- Focal point for communication with customers / interfaces- Preparation of Risk Assessments of the dossiers before dispatch, including technical viability, when applicable.- Responsible for review of CP completeness and gathering missing documents/information from responsible teams for the completion of dossier to be dispatched, according to the legislation.- Translation of the dossiers when required by legislation.- Ensure the quality of dossiers, identifying possible requirements that may be presented, to avoid processing time increase.- Responsible to include in database the dossier and legal documents dispatched to the countries.- Participation in internal meetings and external meetings for training.- Ensure timely dispatch of dossier to the countries in charge.- Make follow-up to RSO of manufacturing site/CMC team, assuring the dispatch of necessary documents for dossier.- Answer opportunely the deficiency letters issued by Health Authorities of the countries in charge.- Give accurate and timely information to maintain regulatory data base updated.- Give visibility to the upper management of main challenges faced locally and provide suggestions of improvement whenever applicable.- About you- Experience: _Relevant experience as a Regulatory Affairs Senior Associate or similar role in the pharmaceutical industry. Experience working with different regulations in a LATAM scope._- Soft skills:- _ Strong stakeholder management and teamwork skills._- _ Excellent negotiation, communication and influencing skills._- _ Demonstrated autonomy and ownership._- Technical skills: _Strong knowledge of regulatory affairs in LATAM region. Knowledge on _biological and vaccines products regulation_._- Education: _Bachelor's Degree_- Languages: _Intermediate English_- Pursue progress, discover extraordinary- Better is out there. Better medications, better outcomes, better science