International R&D and Regulatory Affairs Director M / F Job in Marseille 13013, Provence Alps Côte-D’azur France

Our client, is an innovative actor in the fine chemicals and pharmaceuticals sector, and is carrying a project with very high global stakes. That is why our client is looking for its International  RD and Regulatory  Affairs Director M / F.

Directly reporting to the President, managing a five-people team, you will embody and stimulate research strategy and development using an innovative and original approach, and commit your RD expertise to ensuring an ever going program optimization.
You will need to develop a regulatory strategy to ensure the implementation of pharmaceutical legislation for the development, registration and products operation.

Your main tasks are:

Leading and programming current and new products research strategy and development  on a national and international scale including :

• Pharmaceutical Development :
- Lead manufacturing development processes of the active substance in the CMO: scale transposition, optimization, and other
- Develop the program strategy to develop, improve and change the  pharmaceutical products / processes - dry pharmaceutical forms (tablets, capsules) and liquid (solutions, sprays, injectable ampoules) in CMO and CSO

• Non-Clinical Development :
- Develop the bibliographic and laboratories studies program strategy and pilot its CRO implementation

• Clinical Development :
- Develop the bibliographic and laboratories studies program strategy and pilot its implementation: CTA, IMPD, CRF, monitoring in collaboration with CRO for known and potential indications

• Regulatory Affairs :
- Develop regulatory strategies
- Oversee the writing and follow-up of registration files

• Coordinate the different stages of a project with the different departments (marketing, medical, quality, regulatory affairs, sales force, production ...)

• Draw up budgets and monitor the actual and expected costs

• Service and staff management

 

Scientific referee on your expertise field to the Directorate General your mission is to ensure coordination between the different departments and external partners (including preclinical, clinical, pharmacovigilance, pharmacology, toxicology, and galenic)

Responsible for research programs, you will be involved in executive and policy committees to define strategic researches.

Graduated in pharmacy, regulatory affairs, with a significant experience in the management of a research and development of pharmaceutical or biotechnology service, you have the ability to take products from a preclinical stage to market consumption. You have good management, meeting hosting and project leading skills, which you’ll commit your expertise for.

Innovative, very charismatic, you have a strong, federative and motivating personality for your entire team. Brilliant, inventive, you carry out with enthusiasm, and originality ambitious projects, by thinking outside the box, and proposing a new approach. Responsible, good communicator, you know how to organize, and manage talented staff, relying on a real expertise, and a positive mindset striving for excellence. Visionary, cosmopolitan, you are used to work with different cultures, and are accustomed to international context. Determined, with the capacity to anticipate, you need to leave your own mark by focusing on teamwork, combining pragmatism and utopianism.

Fluent English is required, and notions in at least one other language will be appreciated.