Regulatory Affairs Consultant (MAA) With French Language Skills

We are recruiting for a Fluent French speaking Regulatory Affairs Consultant to support one of our French projects. It is essential that you have MAA experience including promotional materials, safety variations and lifecycle maintenance experience.

As a Regulatory Affairs Consultant you will have the following responsibilities:

- Good understanding of MAA and lifecycle maintenance activities in FRANCE

- Change Control assessment experience (application of relevant regulatory guidance to proposed change)

- Submission experience of Simple (Type I) and complex variations (Type II) to FRANCE in the CP, MRP and NP procedures.

 - Experience in reviewing promotional materials

 - Capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME

- ‘Proactive’ and ‘efficient working method

- Strict adherence to timelines (both internal and HA deadlines)Qualifications• Good understanding of performing the above regulatory tasks on a global level

• Several years of MAA, Safety Variations and Lifecycle Maintenance experience for France.

• Change control assessment experience for EU

• Very good project Management skills

• Proactive approach and excellent communication skills

• Fluent French mandatory, English at least medium level

•Qualified to a degree level in a science based degree