CMC & product specialists
We are looking for 2 Regulatory CMC Specialists / Product Specialists (32-40 hours) in the Netherlands.
The 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. The team 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 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.
- 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
