Senior Ra Cmc Manager

Hrm

Dublin

This innovative global biotechnology organisation is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. A biotechnology pioneer since 1980, this business has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Due to continued expansion and a number of product introductions to the site, a new requirement has arisen for a Senior Regulatory Affairs CMC Manager to lead a RA team at the site. The Role. The RA CMC Senior Manager has oversight of the organisations Site CMC Team and is responsible for providing guidance and leadership to the team, as needed. The RA CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site. The CMC site team interfaces with the site (R&D and operations authors) coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity. The CMC site team are members of CMC product teams and is also responsible for coordination of site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative. The CMC site team is the key RA CMC representative on product deviation investigation teams. The Person. Bachelor's degree and 8 years of directly related experience. CMC- specific regulatory knowledge & experience. Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry. To discover more about this opportunity, apply now or contact Shane Browne at HRM on 353 1 6321865 for a confidential discussion. This job originally appeared on RecruitIreland.com.

1985 days ago