Global Reg-Cmc Sr. Specialist

5 giorni fa

Parma, Italia Chiesi Group A tempo pieno

Who we are looking forPurposeAccountable for:•    Pursuing and executing global, robust and innovative Regulatory-CMC strategies, across the entire life-cycle (pre-clinical, clinical, life-cycle and change management) of Chiesi global products and projects, intended as chemically synthetized or biologics DS, DP, medical devices (including the device component of combination products).•    Acting as GRA representative or leader for CMC topics in the project teams to ensure proper planning and communication as well as to support decision-making.•    Writing of Internal Reg CMC WI/SOP, revision or contribution to GRA or Company documents involving Reg CMC.•    Ensuring appropriate analyses and sharing of CMC regulatory external information/intelligence and active participation in commenting for regulatory-CMC related topics.•    Contributing, as active member of the GRA-CMC LCM Unit, to promote collaboration, communication and the continuous growth in terms of efficiency and excellence, ensuring alignment in the execution, proactive sharing of experience and development of proposals for possible new ways of working [within Units of Chiesi REG-CMC (GRA-GRD) and GRA]•    Building and maintaining relationships within and outside GRA, specifically Global Technical Development (GTD), Global Manufacturing Division (GMD), Global Rare Disease Unit (GRD) and Extended Teams.Main Responsibilities•    Regulatory-CMC representative or leader to Regulatory and Project meetings in alignment with Omnis model•    Independently provides input and expertise for the definition and execution of Regulatory-CMC standards and procedures (including writing of GRA-CMC WIs, SOPs, Tools).•    Accountable, across the entire drug products life-cycle, for Regulatory-CMC strategy development and Quality regulatory documents  preparation, writing and management•    Independently provide regulatory assessment on Change Control, preparing CMC related Development and Life Cycle change management documents.•    Independently interacts with external and internal stakeholders.•    Contributes on collection, analyses, comment and sharing for external regulatory-CMC intelligence and information.•    Provide regulatory CMC review and input to other departments processes and/or documents (i.e.SOPs, Specification Committee, Device documents).•    Provides a specific contribute on identified quality specific areas  as Subject Matter Expert.Experience RequiredIndicatively 5-to-8 year experience in global drug Regulatory CMC and CMC Development.Detailed experience of drug development, manufacturing, and supply processes within the pharmaceutical industry.Demonstrated experience in handling complex global CMC issues through continuous change and improvement.EducationAt least Bachelor's Degree in Chemistry and Pharmaceutical Technology, Pharmacy, Chemistry, Biology or similar.LanguagesEnglish fluentTechnical SkillsExtensive knowledge of the full drug developmentprocess.High-level knowledge of global drug legislation, regulatory procedures and drug development guidelines.Ability to navigate through different quality regulatory requirements.Soft SkillsAdaptability and flexibilityEmotional and social intelligenceNegotiation skillsTeam workingStrategic thinkingWhat we offerYou would join a dynamic, fast-growing, challenging and friendly environment.In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development.Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best.That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.

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