Description
World leading international Pharmaceutical client currently have a long term contract position for an experienced Regulatory CMC SpecialistWorking within Network CMC as part of 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 a minimum of 2 years registration experience in CMC with a strong pharma background to carry out the following tasks & responsibilities:-
* Prepare CMC documentation for international submissions in accordance with local dossier requirements.
* Takes part in the review and release of CMC documents in accordance with the applicable procedures.
* Supervises 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 organization with regard to variations of chemical/pharmaceutical documents following questions from authorities. Consults wit 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:
* MSc (Chemistry, Physics, Pharmacy, Analytical Chemistry) or BSc with multiple years of experience
* Minimum of 2 year registration experience in CMC
* Pharmaceutical background
* Good command of written and spoken English
* Good editing skills
* Has good social skills and is a good team player
* Hands on mentality
* Communicative, assertive and persuasive person
* Good organizational skills