Regulatory affairs - Submissions Expert

Proclinical is working with a specialty pharma that is seeking a Regulatory Affairs Submissions Expert to be based in Paris on a contract basis. This RA Submissions Expert role will ensure regulatory compliance on a portfolio of approximately 125 licences. Obtain regulatory approvals and carry out all regulatory measures to ensure compliance regulations level of responsibility: High Scope: France delegation of responsibility: in the absence of the collaborator, the responsibilities will be delegated to the RA Manager and/or to the regulatory affairs assistant.

Job Responsibilities:

• Identify critical variations for supply plan, prepare and submit variation files.
• Coordination of the variations had when FR is RMS of the procedure.
• Monitoring evaluation until approval perform the required actions on the Trackwise system Validation of Particulars licenses, BAG/BAT updates for packaging items and other regulatory documents for marketed products.
• Provide regulatory support to quality assurance and procurement/Procurement
• Department existing products submission project in ECTD (baseline)
• Follow-up of evaluation to approval Quote/Follow up of price requests.
• Audit of new third-party files (according to business Plan)
• submission of variations required for pre-launch validation of LP "License Particular" (release document)
• validation of new packaging articles prepare/ Validate documents requested by marketing/commercial service
• prepare deposits for new products in-license
• prepare deposits for new products MTO
• creation of EVMPD dossier for new in-license products and complete EVMP records for in-house products provide regulatory support to clients for MTO licenses.
• To ensure compliance with the regulations on drug advertising.
• Training of trainees in regulatory affairs
• assist the sales team in responding to tenders to
• lead other projects defined by regulatory management.

Skills and Requirements:

• 3 years' experience in regulatory affairs in the pharmaceutical industry or health authorities
• Good knowledge of national regulatory requirements, European regulatory directives,
• Fluency in French and English
• Sense of customer service
• Good communication skills be
• Attentive, proactive and be force of Proposition

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Badria Kahie on +44 203 8718 094 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.