Regulatory and Pharmaceutical Affairs Manager
Description
Do you want to be part of our collaborative team in France and gain broader experience to elevate your career?
At Shionogi we believe in doing things differently. In Europe, our unique DNA combined with our Japanese roots drives a strong and rapidly growing European operation. Central to our business is the real belief that ‘everybody counts’. That means that everybody in the organisation is valued for their personal contribution. We actively develop and support our employees to be the best they possibly can, building on their skills and adding new capabilities for themselves.
We have a history and heritage of providing critical medicines for over 145 years. Our driving focus is caring about people and “Putting Patients First”. We believe and live our values. For you this means we offer early responsibility and opportunity to develop into the role, in a contemporary and fun place to work.
Working as part of our team in France, you will be responsible for regulatory affairs and contribute to the relevant pharmaceutical liability processes.
You will be responsible for:
- advertising and non-promotional activities control,
- training material validation,
- maintaining and improving the certification system for promotional information,
- compliance oversight of interactions with healthcare professionals and organizations,
- packaging items validation, variations monitoring, and new products launch.
You will also participate in:
- continuous improvement activities and management of the quality system: monitoring of procedures, self-inspections, quality indicators, deviations, CAPA, change controls, risk assessment, etc.
- audits and inspections,
- management and monitoring of subcontractors.
This position is an excellent opportunity to work in a collaborative environment and work as part of a close-knit team to gain broad experience across regulatory and pharmaceutical affairs. This is a high-profile role within the business giving you the chance to build face-to-face relationships internally.
We are looking for someone who is looking to further their experience through working in an autonomous environment. In addition, we need you to have:
- Doctor of Pharmacy, registrable in Section B of the CNOP and ideally as deputy responsible pharmacist
- Experience in a pharmaceutical establishment with mandatory experience in advertising control
- High level of commitment, integrity, adaptability, and autonomy
- Ability to manage emergencies and priorities
- Ability to assess risks
- Ability to develop a strategic vision while ensuring operational activities
- Knowledge of the benefits management law would be a plus
- Good communication skills
- Fluent English and native/fluent French
If this sounds like you, please apply. We look forward to hearing all about you.