Global Regulatory Affairs Consultant

Real

Les Ulis

Sur place

EUR 45 000 - 65 000

Plein temps

14 jours+

Générateur de candidature

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Résumé du poste

A leading pharmaceutical company seeks a Global Regulatory Affairs Consultant based in Île-de-France. The role involves compiling regulatory submissions, providing expert advice, and maintaining compliance with industry standards. Ideal candidates will have relevant academic qualifications and should demonstrate strong regulatory expertise and communication skills. This temporary position is designed for professionals looking to make an impact in regulatory affairs within the pharmaceutical sector.

Qualifications

Bachelor's degree in pharmacy or related discipline essential.
3-5 years of regulatory experience preferred, with higher degrees advantageous.
Experience with CTD and EU regulations is a plus.

Responsabilités

Compile and submit regulatory documents according to timelines.
Provide expert advice and manage regulatory inquiries.
Drive lifecycle management and represent Regulatory Affairs in projects.

Connaissances

Regulatory Compliance

Communication

Negotiation

Project Management

Technical Proficiency

Formation

Bachelor's degree in pharmacy or related scientific discipline

Outils

Word processing tools

Spreadsheets

Databases

Description du poste

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Our client, a leader in the industry, is looking for a Global Regulatory Affairs Consultant to join their team on a contract basis. This role is integral to supporting regulatory initiatives, new registrations outside of the EEA, and regulatory lifecycle management. If you have a passion for navigating the complex world of regulatory compliance, this opportunity is for you.

Key Responsibilities

Compile and submit regulatory documents according to requirements and timelines.
Provide expert regulatory advice to project teams and ensure timely responses to regulatory authority inquiries.
Maintain regulatory documentation in compliance with CTD and EU regulation standards.
Drive lifecycle management plans, including variation submissions and supporting device registrations.
Represent Regulatory Affairs in cross-functional project teams.
CTD and CMC Expertise: Proven ability to work with Common Technical Documents and Chemistry, Manufacturing, and Controls data.
EU Regulation Knowledge: Strong understanding of MRP/DCP procedures and international regulation frameworks.
Scientific Knowledge: Comprehensive knowledge of pharmaceutical sciences.
Communication: Excellent verbal and written communication skills in English.
Negotiation: Capable of managing regulatory discussions effectively.
Technical Proficiency: Skilled in using word processing tools, spreadsheets, databases, and conducting online research.
Project Management: Ability to manage multiple projects with strict deadlines.
Compliance Awareness: Detect compliance risks and take appropriate actions swiftly.

Qualifications

Bachelor's degree in pharmacy or related scientific discipline.
3-5 years of regulatory experience within a pharmaceutical company, CRO, or similar organization (higher degrees such as a PhD are advantageous).

Seniority level