Description
Regulatory Affairs CMC SpecialistWorld 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 for our client with registration experience in CMC with a strong pharma background to carry out the following tasks & responsibilities:-
* Prepare CMC documentation for USA FDA submissions in accordance with local dossier requirements.
* Take part in the review and release of CMC documents in accordance with the applicable procedures.
* Supervise the compilation of CMC dossiers.
* Answer questions from health authorities and coordinates the Agency Response process.
* Conversant with relevant, worldwide registration requirements
* Conversant with literature relevant to the projects and products assigned to him/her.
* Makes proposals to the organisation with regard to variations of chemical/pharmaceutical documents following questions from authorities. Consult with the departments involved.
* Has contacts with staff of global groups, local companies and other sister companies.
* Sees to planning, coordination and implementation of all the tasks related to his/her project.
Requirements:
* Registration experience in CMC essential - preferable strong validation documentation experience.
* Pharmaceutical background
* Experience working with FDA submissions desirable
* Good command of written and spoken English
* Good editing skills
* Excellent social skills and team player
* Hands on mentality
* Communicative, assertive and persuasive person
* Good organisational skills