Description
Regulatory CMC Intelligence ManagerWorld leading international Pharmaceutical client currently have a long term contract position for an experienced Regulatory CMC Specialist.
Working within the Global CMC team - responsible for carrying out regulatory activities of site changes to chemical/pharmaceutical aspects of the submissions, we are looking for a Regulatory CMC specialist with registration experience in CMC with a strong pharmaceutical background to carry out the following:
Tasks & Responsibilities:-
Is the centre of knowledge in Network CMC with respect to regulatory requirements and Health Authority expectations for CMC submissions and corresponding submission procedures.
Advises on filing strategies for Network CMC derived submissions.
Collects Intelligence based on multiple sources (info from local RA representatives, existing and new guidelines, Health Authority responses on earlier submissions) and provides interpretation and practical consequences.
Is the point of contact in Network CMC for the existing Regulatory Guidelines Database, a regulatory CMC requirements database with key data on dossier content and submission procedures per country/region.
Provides maintenance support to the database as needed, based amongst others on analysis Health Authority feedback and new legislation.
Is the Database expert in Network CMC and trains and advices on the use of the database in Network CMC
Advices in and outside Network CMC about interpretation of guidelines and provides best practices for dossier content and submission strategy
 Contacts local RA representatives and advices on planned submissions
Job criteria / requirements:
BSc or MSc (Chemistry, Physics, Pharmacy, Analytical Chemistry) with multiple years of experience.
Experience in Pharmaceutical CMC or Regulatory Affairs essential.
Good command of written and spoken English.
Command of Dutch language is an advantage, but no must
Good editing skills.
Has good social skills and is a good team player.
Communicative, assertive and persuasive person
Good organizational skills
Is conversant with relevant, worldwide registration requirements
This is an exciting opening to work in dynamic team in a contract opportunity offering competitive rates of pay. Please apply now at or on for more information.