Regulatory Affairs Associate

Summary

Directly reporting to Pharmaceutical Affairs Director, the Regulatory Affairs Associate ensures support in all activities relating to pharmaceutical affairs, regulatory affairs, pharmacovigilance and quality assurance in accordance with Incyte processes and with local and European legislation.

Duties and Responsibilities

Management of regulatory activities specific to an Exploitant company for the products distributes by Incyte Biosciences France:

·Control and monitoring of communication documents: regulatory validation, submission to authorities, document management and monitoring,

·Monitoring of regulatory activities: translations, PGR, packaging management, legal notices.

·Control and monitoring of communication documents: regulatory validation,

·Monitoring of current projects in collaboration with Corporate Europe.

Participation in all other activities of the Pharmaceutical Affairs Department for pharmaceutical distribution company and more specifically:

·Monitoring and organizing (in collaboration with the EU Supply Chain department) the distribution of pharmaceutical products distributed in France,

·Participation in the training of Incyte Biosciences France employees,

·Participation in pharmacovigilance activities, in collaboration with the Local QPPV,

·Participation in any other mission related to current projects.

Requirements

·Doctor in pharmacy or equivalent, registerable in section B of the Order of Pharmacists

·A previous successful experience in “Explointant” pharmaceuticals affairs

·Solution orientated with excellent problem solving skills,

·Perfect communication skills,

·Discretion & ability to handle sensitive information,

·Well organized and reliable,

·Able to honor deadlines,

·Excellent proficiency with Office software systems (Excel, Word, PowerPoint) and Outlook,

·French and Scientific and technical English mandatory

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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