For a world leading international pharmaceutical company,  we are seeking for:

2 Regulatory CMC Specialists / Product Specialists
(32-40 hours)

for the department of Network CMC (Chemistry Manufacturing & Control in Oss, the Netherlands.

The Network CMC team is responsible to carry out regulatory activities that are needed in the context of site changes, in particular with respect to chemical/pharmaceutical aspects of the submissions.Network CMC is part of Quality Assurance and Pharmaceutical CMC.

The position will start with a 12 months contract, but as the project is expected to be continued, it is very likely that the contract may be extended for a period of about 3 to 4 years .

Tasks and Responsibilities:

·          Prepares 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.

·          Answers questions from health authorities and coordinates the Agency Response process.

·          Is conversant with relevant, worldwide registration requirements.

·          Is 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.

·          Takes the initiative for and coordinates additional studies which are performed by the chemical/pharmaceutical disciplines.

·     Has contacts with other MSD staff of 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.

·    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