LOCATION: CORK, IRELAND***
The Associate, Regulatory CMC, Regulatory Delivery Excellence (RDE) leads, in partnership with the GRA-CMC RA Scientists, the various aspects of global marketing authorization submission management processes. The Associate also partners with GRA-CMC Scientists to help create and manage Leo/Regulus submission content, and to provide guidance on structure and content placement within CTD registration submissions, and to provide assistance with submission related Ministry of Health responses or company’s affiliate questions. The Associate works within regulations to expedite the registration and lifecycle maintenance of products. This is accomplished by a strong working knowledge of internal procedures, guidance’s and regulatory precedence. Regulatory CMC Associate will triage and manage the communications between our Affiliates, GRA-CMC Scientists, Specialists, and the Quality/ Reg Representatives and utilizes GRA-CMC submission process expertise and their expertise with Information Technology tools to develop project management expectations across projects. Based on implementation and supply chain needs within manufacturing, he/she will be responsible for routine communication of submission tracking requirements to both GRA-CMC Scientists and internal customers. The scope of work includes global regulatory requirement assessment and strategy development, coordination of submissions with the submission specialists, and project management for marketed product support.
Minimum Qualification Requirements:
Other Information/Additional Preferences:
Job location: Cork, Ireland (relocation package available) Global pharmaceutical company is looking for a Medical Information Analyst (Italian or Dutch or Italian&Spanish speakers): Main...Apply For This Job
***LOCATION: CORK, Ireland (MULTINATIONAL PHARMACEUTICAL COMPANY) ***EU/UK Passport or Stamp 4 Visa required Medical information provides answers to...Apply For This Job
***LOCATION: CORK, Ireland (MULTINATIONAL PHARMACEUTICAL COMPANY, funded relocation) ***EU/UK Passport or Stamp 4 Visa required RESPONSIBILITIES: Be a...Apply For This Job