Want to work in a dynamic company with daily new challenges and opportunities? Then is PharmaLex your career opportunity. PharmaLex is one of the leading service companies for the global pharmaceutical industry and specializes in all aspects of drugs and medical devices approval of the development to market and any action to product maintenance make it as effective as possible.
The success of our company grows with the excellent expertise and the high motivation of our employees. If for you, your profession is not only a job but a mission too and you enjoy working with people, then you are welcomed to come and join us. To strengthen our successful team in France we are looking, as earliest as possible, for a :
Senior Regulatory Affairs and New Product Development (Medical Devices)
- To ensure the scientific and technical/regulatory relevance of development plans implemented for products developed by the laboratory and the optimisation / transfer of existing products, in relation to the finished product (FP) as well as the active substance (AS), medical devices (MDs) and cosmetics (C).
- To apply his/her technical expertise for quality purposes for products (AS/FP/MD/C) developed and manufactured by subcontractors with a view to their clinical use, registration and marketing.
- To help develop regulatory strategy.
- To provide technical expertise to ensure quality of CLIENT products, medical devices, cosmetics or pharmaceuticals.
- To draw up quality documentation (modules 2.3, 2.4, 3 and 4) for registration dossiers and the technical part of the Technical Files (MD) and Product Information Dossier (DIP) (C).
- To manage the development/validation of bioanalysis methods to support preclinical and clinical studies.
- To manage new product development projects:
- Determine pharmaceutical/MD/cosmetic development plans, checking their technical relevance and compliance with the applicable practices, regulations and guidelines.
- Identify, select and qualify subcontractors and suppliers required for the implementation of projects or take part in these tasks with SC, Purchasing, and Quality in the case of production subcontractors.
- Draw up technical specifications/Design and Conception for MDs and take part in the review of contracts and the evaluation of financial proposals setting out the duties of subcontractors and suppliers.
- Coordinate the implementation of pharmaceutical/MD/cosmetic development plans, focusing in particular on compliance with the budgets and timelines set within the project team.
- Act as the point of contact for project teams for all matters relating to product development/pharmaceuticals/MDs/cosmetics.
- Take part in the development of product Life Cycle Management strategies.
- Provide scientific expertise for the development of new CLIENT products.
- Bac + 5 Scientific Higher Education Diploma (Master’s degree) as a minimum.
- Knowledge of development within the pharmaceutical industry and of the regulatory environment in relation to the development of medicinal products/MD/Cosmetics with a view to their registration.
- Desirable: Experience in the production or quality control of dry formulations and background in chemistry or Galenic scienceExperience of drafting Quality/Technical dossiers
- Knowledge and practical experience of GMP and of a quality system.
- Good writing skills
- Fluent English (reading, written and spoken)
- Ability to work independently, discipline.
- Ability to analyse and summarise information.
We offer you
- 6-month contract in a dynamic and growing environment
- We foster commitment – while giving room for flexibility
- We promote and demand – while allowing a work-life-balance
- We motivate people – we think ahead
We bring people together – while focusing on connectedness
If you are interested to take over this most challenging job opportunity in our future-oriented company and want to develop as well as our company, we look forward to receiving your application documents stating your earliest possible starting date and salary expectations online.
Ms. Laura Escabias
Senior European Recruitment Specialist