Regulatory Affairs Associate

TN France; Boulogne-Billancourt; Sur place; EUR 40 000 - 70 000; Plein temps

Résumé du poste

An established industry player is seeking a Regulatory Affairs Associate to support pharmaceutical and regulatory activities. This role involves managing regulatory documents, collaborating with various departments, and ensuring compliance with both local and European regulations. The ideal candidate will have a Doctor in Pharmacy or equivalent qualification, along with previous experience in pharmaceutical affairs. Join a dynamic team where your expertise will contribute to the distribution of vital pharmaceutical products in France. If you are solution-oriented and possess excellent communication skills, this opportunity is perfect for you.

Qualifications

• Experience in pharmaceutical affairs with a focus on regulatory compliance.
• Strong problem-solving abilities and excellent communication skills.

Responsabilités

• Manage regulatory activities and ensure compliance with local and European legislation.
• Collaborate with the EU Supply Chain department for product distribution.

Connaissances

Problem Solving

Communication Skills

Organization

Discretion

Regulatory Affairs Experience

Pharmaceutical Knowledge

Technical English

Formation

Doctor in Pharmacy

Equivalent Qualification

Outils

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Microsoft Outlook

Description du poste

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Regulatory Affairs Associate, Boulogne-Billancourt

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Client:

Incyte

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

d5e3aa5e6e51

Job Views:

1

Posted:

06.05.2025

Expiry Date:

20.06.2025

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Job Description:

Overview

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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