About us: Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use. Chemo, industrial area of the Insud Pharma group, is a world leader in R&D and manufacturing of more than 100 value-added active pharmaceutical ingredients and more than 122 medicines with more than 200 different product presentations. Chemo produces its own active pharmaceutical ingredients (API) as well as finished pharmaceutical products (FDF) covering the main therapeutic groups (Cardiology, Gastroenterology, Central Nervous System, Anti-infectives, Respiratory, Women's Health, Endocrinology, Dermatology and Urology). COMMITMENT TO EQUAL OPPORTUNITIES Insud Pharma is aware that business management has to be in line with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current legislation on the subject - Organic Law 3/2007, and we do not discriminate against any person on grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance. General Responsibility Technical support to the commercial project of the API Division. The Technical Department technician receives the customer's requests and prepare a response considering the current guidelines in the pharmaceutical industry, in the different countries, and according to the pharmacopoeia applicable in each area; contacting specific departments of the different the manufacturing facilities, if necessary, to assure a suitable response in a timely manner. Supervise and review work related to internal development project management. Specific Responsibility Process customer's requests, review them, solve them and, if necessary, address them to different factories and track them. Send the final answer, including the required documentation, to the final customers. Customer Specification management. Registration of all the information related to the technical assistance provided to the customers and API manufacturing sites (CRM). Follow-up the products' acceptance in different countries and the feedback received by customers. Collaborate with the Regulatory Affairs Departments in the preparation of their marketing authorization applications. Manage of the regulatory documentation. Support to APIs Manufacturers (both Internal Sites and External Sites). Provide alternatives or contingency to changes or problems in execution solutions. Ensure projects are complete, current and stored appropriately Samples for Pharmacy Office management Requirements Education: Degree in Sciences. Master in Pharma Industry will be asset. Languages: Fluent English, knowledge in other languages will be an asset. Experience (years/area): 1-2 years in a similar position in the pharmaceutical industry, related with API products will be an asset Specific Knowledge: Knowledge of Regulatory Affairs procedures and guidelines. Handle of the different pharmacopoeias. Knowledge of Office and CRM tool is a plus.