Cmc Facilitator - Colleretto Giacosa, Italia - Novartis

Novartis

Azienda verificata

Colleretto Giacosa, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

386156BR

CMC Facilitator:

Italy

AAA Statement

Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients' lives by leading innovation in nuclear medicine.

Advanced Accelerator Applications, a Novartis company, offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

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 preevaluation 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 crossfunctional and crosssite 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 coauthoring 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 submissionrelated activities e.g. transfers, ensuring activities completed without delays. Address and escalate issues adequately and in time.
Provide onsite 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 followup 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.

Commitment to Diversity & Inclusion:

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 groundbreak