Senior Global Regulatory Affairs Cmc Manager Parma

Senior Global Regulatory Affairs Cmc Manager
Parma
Emilia Romagna, Parma

Who we are looking forPurposePursuing and executing global, robust and innovative Regulatory-CMC strategies, across the entire life-cycle with focus on Marketing Authorization Application but generally on all phases (mainly 1-3 of development, but also pre-clinical and post-approval activities) of global products and projects, primarily on chemically synthetized DS, DP as well as medical devices (including the device component of combination products).

Competence on inhalation products is an important part of profile.

Ensuring appropriate analyses and sharing of CMC regulatory internal and external information/intelligence and active participation in commenting on regulatory-CMC related topics.

Competence on Biologics is a plus. Main ResponsibilitiesAccountable and Responsible, for drug products Regulatory-CMC strategy development and Quality regulatory documents (Quality-IMPD/IND, Quality part of Briefing Documents, M2. 3, M3, ) preparation, writing and management. Be the Regulatory-CMC representative or leader to Regulatory and Project meetings. Provide input and expertise for the definition and execution of Regulatory-CMC standards and procedures (SOPs). Provide regulatory assessment of Change Control, preparing and giving CMC-RA relevant input on CMC related Development and Life-cycle documents. Check international regulatory websites to proactively verify Guidelines (ICH, EMA, FDA & other).

Experience RequiredAbout 5/6 years of experience in global Drug Regulatory CMC and CMC Development and the adjacent CMC areas (analytical,  manufacturing process, stability etc).

EducationBachelor's Degree in, Chemistry and Pharmaceutical Technology, Chemistry (or Biology, Biotechnology).

Advanced degree (M. Sc/ PhD) in a related discipline is a plus.

LanguagesFluent EnglishTechnical SkillsKnowledge of the full drug development process. Knowledge of global drug legislation, regulatory procedures and drug development guidelines. Ability to navigate through different quality-CMC regulatory requirements. Understanding of technical aspects is a plus (ex: analytical methods for Inhalation Drug product analysis and characterization, manufacturing processes etc).

Soft SkillsAdaptability and flexibilityDecision makingGoal orientationLeadership and social influenceLocationThe role can be based in Europe, prefarably where an R&D center is located (Italy, UK, France and Sweden)What 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.