With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries. At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves. This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases. Recordati. Unlocking the full potential of life. Job Purpose Responsible for the Chemistry, Manufacturing and Control (CMC) aspects of Recordati Rare Diseases (RRD) products/projects for submission to regulatory authorities (all submissions: initial and answers to questions). Key Responsibilities Responsible for the Regulatory Chemistry, Manufacturing and Control (CMC) aspects of RRD projects/products (maintenance and life cycle management of existing products). Contribute to the development of new projects in collaboration with Recordati HQ global pharmaceutical development team. Responsible of the necessary documentation of registration dossier (IMPD, CTD or other formats) from CMC (chemistry, manufacturing and controls) viewpoints following an in-depth review and analysis of the existing documents. Take in charge the writing and compilation of the CMC part of IMPD and CTD dossiers (Modules 2.3 and 3) for new projects, line extensions of existing products, variations and maintenance of existing dossiers new Marketing Application in EU and ROW, PIP and Response to Questions Responsible for strategy of CMC part of all submissions: all initial applications and answers to questions Lead Risk assessments of CMC assigned projects. Maintain product compliance through appropriate regulatory filings and activities Support Change Control Management activities Participate as an active member of cross-functional teams as needed Required Education Diploma of chemistry or pharmacist 8 years working experience in CMC regulatory affairs Experience in chemistry, manufacturing and controls (CMC) and writing CMC part of any regulatory dossiers for Chemical Biologic and combination product ( experience in rare disease will be a plus) Required Skills And Experience Knowledge of good manufacturing practices GMP, GCP, GLP Experince from early development to late stage Excellent interpersonal skills Able to take decisions Effective presentation and communication skills Skilled in time management and able to meet deadlines Ability to work across cultures Conflict solving abilities Initiatives and self motivation abilities Creativeness Flexible and adaptable Technical Competencies analytical chemistry / extractables & leachables / early phase development / manufacturing environment / Medical Devices / Biologic/ stability data protocol/MCB and WCB/comparability study/ specifications Required Behaviours And Competencies Buying into the Recordati Rare Diseases/Recordati identity Positive thinking and behaviour Required Languages Fluent in English At Recordati we believe in people Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential. We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief. If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.