Description
Regulatory Affairs Manager - CMC - Two Year Assignment - Holland - Dutch and English Speaking.A global market-leading pharmaceutical client is seeking an experienced regulatory affairs manager to coordinate an international project which aims to complete name changes on a range of products after the sale of a key part of the business to another Pharmaceutical organisation.
Responsibilities will include but are not limited to:
-Defines and executes the registration strategy for submission of the API manufacturer name changes worldwide.
-Prepares and submits chemical and pharmaceutical manufacturing and control (CMC) documentation and ancillary documents worldwide.
-Leads or participates in discussions with local Merck Registration Managers and with the Health Authorities worldwide with respect to planned or submitted changes.
-Responds to agency or subsidiary questions.
-Maintains planning and tracking systems
-Participates in relevant project teams
-Supports new and existing CMC systems (RCAM, ORION, QSIS) and assures compliance with those systems
The following skills and experience are required:
-Dutch and English Speaking
-International registration experience, preferably in CMC
-Experience with respect to interaction with health authorities
-Demonstrated knowledge of regulations related to CMC, quality and GMP.
-Ability and experience to manage projects to achieve high productivity, prioritize and manage effective meetings.
-Quality driven, innovative, flexible and collaborative.
-Effective problem solving and decision making skills.
This is an excellent opportunity with a lucrative two year duration, the successful candidate will be working with an innovative industry leader.