Regulatory Affairs Manager/Senior Manager – CMC

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8bjo7w

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join our global Regulatory Affairs team in a client-dedicated role supporting commercial medicinal products used in clinical trials, including comparator and auxiliary medicinal products.

This highly client-facing position combines EU/EEA regulatory assessment, CMC and labelling expertise, regulatory change control, Summary of Changes preparation, regulatory intelligence and cross-functional coordination .

Strong CMC expertise is essential; however, the primary focus is broader than CMC authoring. The role will assess proposed changes, determine regulatory impact, coordinate implementation activities and support the development of effective processes and ways of working.

What You'll Do
- Perform EU/EEA regulatory assessments of changes , applying applicable legislation, EU Clinical Trials Regulation requirements and regulatory guidance.
- Assess the impact of CMC, manufacturing, supply and labelling changes on clinical trial documentation and determine appropriate regulatory actions,



including substantiality assessments where applicable.
- Prepare and maintain Summary of Changes (SoC) documentation.
- Manage:
- Product-specific changes impacting sIMPDs, SmPCs and clinical labels.
- Non-product-specific changes impacting manufacturing/release site lists, manufacturing licences and GMP certificates.
- Review and compare revised SmPCs, clinical labels, manufacturing licences, GMP certificates and related documents to identify and assess relevant changes.
- Provide CMC regulatory expertise and support targeted authoring, updating or expert review of sIMPD and other CMC documentation when required .
- Coordinate regulatory change-control activities , including planning, stakeholder coordination, action follow-up and maintenance of trackers and systems.
- Provide regulatory intelligence and practical interpretation of EU/EEA requirements in response to client and cross-functional ques

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8bjo7w