Regulatory Affairs Support for EU & LATAM.Marketing Authorization: Pre-submission activities • Regulatory Strategy preparation • Preparation and/or Consolidation of documents for all Modules of the dossier• Module 1 review / GAP analysis / preparation• Module 2.4, 2.5, 2.6 and 2.7 creation – Medical Writing support• Module 3 GAP analysis / CMC dossier writing• Module 4 and 5 creation• Dossier Compliance review • Regulatory Advice for GMP Inspection • Review of the final dossier prior submission• Labelling and packaging materials support Marketing Authorization: Submission and Registration activities • Submission of the final dossier in most regulated regions • Full support and preparation of deficiencies responses • Communication and follow-up with Competent Authorities during the registration process• Support for finalization of the procedure• Orphan drugs applications• Marketing Authorization: Post-submission and Post- Authorization activities • National Phase management • Variations, renewals, and eCTD lifecycle maintenance• MA transfers and associated variations management

Responsible for client's consultations, setting and executing regulatory activities within Regulatory Affairs department projects. Major roles and responsibilities:1. Manage regulatory affairs designated projects; 2. Develops and execute regulatory strategy for designated project;3. Liaison with international regulatory agencies as appropriate;4. Development of content and submission for complete and quality regulatory filings;5. Work cross-functionally and in collaboration with key stakeholders/customers6. Maintain and improve the regulatory system and procedures.Effectively manage and build working relationships with all stakeholders, based on transparency, trust and clear communication; delivering solutions to stakeholders and delivering quality expectations. Essential Duties and Responsibilities:• Manage regulatory affairs designated projects; • Cooperate and communicate with the assigned clients and vendors;• Liaison with international regulatory agencies as appropriate;• Develops and execute regulatory strategy and accurate submission planning for designated project;• Compile/create registration dossier in the CTD, eCTD or another format according to the current legislative requirements of the given country for all types of processes - new registration, renewal, variations), as per clients need and request;• Review of all documents prior submission or transfer to authorities/clients; • Overseas labelling up-dates, as per clients need and request;• Manage product life-cycle, as per clients need and request;• Reports submission development, submission and approval status, according with project governance settings;• Ensure proper archiving of all documents submitted to authorities and/or sent to clients;• Regular and accurate updating of internal or external reporting documents;• Active participation in assessment of impacts and risks resulting from changes in legislation; • Maintain and improve the regulatory system and procedures;

General Project Management activities:• Supervising and coordinating multiple projects, covering all activities related to the development, production, registration and marketing of medicinal products and medical devices, both in the EU and other regions.• Coordinating and cooperating with other departments (business development, RT, translation and artwork department) to ensure that projects run smoothly and deadlines are met.• Coordinating with clients from a variety of backgrounds and industries regarding ongoing projects.• Prioritize many different types of projects on varying timelines to ensure compliance with deadlines and legislation requirements.• Follow current SOP guidelines regarding procedural steps throughout the entire life cycle of the project. Ensure that the steps are accurately completed in order to provide high quality services.Regulatory Affairs activities:• Submitting registration documents to regulatory agencies, and carry out all the subsequent negotiations and activities necessary to obtain and maintain the marketing authorization for the products.• Working closely with government agencies to ensure all legislation is closely followed and the clients' products comply with the regulations.• Cooperating with the technical team, experts across our international offices and suppliers to ensure quality in all projects is consistent.• Follow the industry news and new government legislation to discover upcoming or new situations that will impact the projects. Share any information that may be relevant with all parties.Documentation:• Preparing and revising regulatory documentation to ensure it is compliant with the relevant legislation.• Maintain highly organized records of all correspondence and documentation relating to each individual project.

- International Registration of Medicinal Products for the following countries: China, Vietnam, Lebanon, Yemen, Azerbaijan, Syria, Uzbekistan, Hong Kong, Iraq, Tajikistan, Kazakhstan, Moldova, Ukraine, Bolivia, Uruguay, Paraguay, El Salvador, Dominican Republic, Venezuela and Guatemala.- Preparation of dossiers for registration and / or modification of Medical Specialties in the National Administration of Medicines, Food and Medical Technology (ANMAT), Argentina.- Armed of Technical Documentation.- Request for Legal Documentation.- Management of Certificate of Pharmaceutical Products (CPP) and Free Sale Certificates (FSC) and Good Manufacturing Practices Certificates (GMP) at the Argentinian Ministry of Health. - Re-registration of certificates and maintenance.- Agency and literature search.- Review and update of dossier in CTD (Common Technical Document) format.- Records Management for registration.- Update pharmaceutical regulations.- Preparation of reports of stability, manufacturing methods, control and reporting of bioequivalence.- Batch Record Management documentation.- Management of GMP / GLP.

- Preparation of dossiers for registration and modification of medical specialties, cosmetics and household sanitary products at the Argentinian Ministry of Health.- Approval of labels for product registration submission to Household Hygiene and Cosmetics.- Monitoring of current files.- Management of Free Sale Certificate for import / export products.- Compilation of technical documentation required for the assembly of monographs.- International Products Registration in Paraguay, Uruguay and Bolivia.- Armed and translations of Material Safety Data Sheet (MSDS).- Maintenance and updating of physical and digital documents in the area.- Charging documentation for exports and imports.- Management of monthly accounting close area.