About the Role

　　The CMC Facilitator supports and facilitates on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the site specific (global and local) products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements.

　　Your key responsibilities:

　　Your responsibilities include, but are not limited to:

　　• Act as single point of contact and advisor for worldwide regulatory intelligence information on the site. Maintain a partnership with RA CMC members / management and RA in order to keep track of new regulatory requirements, strategies and the knowledge of the global product dossiers (CTD module 3).

　　• Collaborate and provide advice on implementation of new regulatory requirements and advice and guidance on regulatory and change control related aspects.

　　• Participate in the CMC facilitator network sharing lessons learned, providing expertise to facilitators from other sites and raising and resolving issues.

　　• Coach, train and develop the site's personnel on regulatory specific aspects of change management by sharing lessons learned and regulatory intelligence information with the goal of improving skills and capabilities for handling change requests and maintaining regulatory compliance, and support sites in setting standards for regulatory relevant information included in CMC modules to achieve consistency in level of detail and type of information provided.

　　• Support the site in generation of effective change control strategies. Verify the regulatory relevance of changes - includes performing regulatory pre-evaluation of changes. Provide regulatory strategic guidance as member of local change control board.

　　• Consider current regulatory requirements and trends in order to ensure accuracy and completeness of regulatory relevant information in the change requests while including potential regulatory hurdles.

　　• Identify needs and lead cross-functional and cross-site initiatives as applicable within and beyond the site context to improve and elaborate processes e.g. addressing gaps and/or achieving improvements in change control process.

　　• Guide the site to optimally support the CMC documentation preparation by facilitating timely provision of good quality source documentation, involving co-authoring as applicable, and accurate comments from technical experts to RA CMC while ensuring regulatory compliance, quality oversight and adherence to best practices. Monitor project scope, timing and progress of submission-related activities e.g. transfers, ensuring activities completed without delays. Address and escalate issues adequately and in time.

　　• Provide on-site coordination, guidance and support for the preparation of CMC responses to Health Authority (HA) questions for site specific products, balancing internal and external customer focus considering Novartis global interests. Ensure overview and timely follow-up to commitments impacting the site.

　　• Support and address issues related to regulatory compliance checks. Maintain an oversight of any compliance remediation activities at the site, ensuring appropriate handling and prompt completion of remediation activities.

　　Diversity & Inclusion / EEO

　　We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

　　Role Requirements

　　What you'll bring to the role:

　　• Scientific Degree.

　　• At least 6 years' experience in a similar role within a pharmaceutical manufacturing site or experience in QA/QC or in technical development.

　　• Fluent in English and Italian.

　　• Project management experience.

　　• Previous experience in Regulatory Affairs CMC desirable.

　　Why Advanced Accelerator Applications?

　　Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

　　Imagine what you could do at Novartis!

　　Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

　　Division

　　Oncology

　　Business Unit

　　ADVANCED ACCELERATOR APPLICATIONS

　　Location

　　Italy

　　Site

　　Colleretto Giacosa

　　Company / Legal Entity

　　AAA Italy Srl.

　　Functional Area

　　Quality

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No