Senior Manager Regulatory Affairs at Servier

Job description

In direct report to the General Manager and in contact with the Regulatory Affairs department of our Headquarters in Paris, your main missions will be:

• Coordinate and submit the alterations post-records, registrations and product renewals, reply the authorities’ demands adequately.
• Support in the elaboration of prices for the registration processes.
• Accompany inspections and audits. Answer the demands of the Sanitary Authorities to obtain the licenses and authorizations, as well as to accomplish the maintenance of its information.
• Take part in meetings with the pertinent Sanitary Authority. Establish and maintain good relationship with the Authorities to leverage the company's image.
• Coordinate and submit the renewals of the certificate of Good Manufacturing Practices.
• Keep, improve and to develop internal processes according to the quality requisites, local legislation and head office procedures.
• Give consultancy to other departments in the regulatory area and legislation.
• Support the local management in the legal action process, budget and plan definition and accomplishment

Skills required

• Ability to deal with a complex legal and political environment
• Well-organized, able to prioritize and manage workload, follow up of processes.
• Ability to build strong and durable relationships within the company and with the regulatory agencies and the decision makers of the registration process

Education level : Pharmacist or Medical Doctor

Experience : you should have a previous experience of 3 or 5 years in a similar position, preferably in an international environment.

Languages : Fluent English