Regulatory Strategy Specialist - Signes, France - IPSEN

IPSEN

Entreprise vérifiée

Signes, France

il y a 2 semaines

Posté par:

Sophie Dupont

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Description

Title:

Regulatory Strategy Specialist

Company:

Ipsen Pharma Biotech (SAS)

Are you a CMC Regulatory or a medical device professional with excellent attention to detail? Have you experience in preparing CMC-Regulatory documentation and/or experience in preparing technical files for medical devices?

If so, we are currently recruiting for an CMC Regulatory Strategy Specialist to join our Global CMC Regulatory team based at Ipsen Dublin.

This dynamic team is responsible for the management of substance and drug product activities for a number of Ipsen's commercially approved products as well as supporting the management of medical devices within Ipsen.

There is great opportunity to develop your skills within this diverse role.

The successful applicant will have an understanding of CMC-regulatory activities and or medical device management. Experience working in an international environment/global organisation would be beneficial. The applicant should be a critical thinking individual with excellent written, verbal and interpersonal communication skills.

Ipsen in Ireland is represented by a dynamic state-of-the-art manufacturing facility, creating API for our key products.

The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference.

We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people's lives.

The CMC Regulatory Strategy specialist will be responsible for performing CMC Regulatory activities to to support drug substance and drug product activities for Ipsen's commercially approved products and medical device management:

Your role will include:

Developing a CMC Regulatory strategy for regulatory submissions in all relevant markets worldwide.
Compiling regulatory technical documentation including updating CTD sections with process and analytical data extracting information from reports, batch records, analytical procedures, etc.
Compiling regulatory technical documentation for medical devices.
Responding to questions from Regulatory Authorities in all relevant markets worldwide
Working effectively with Global Regulatory Affairs and Ipsen Alliance Partners to support and prepare CMC-Regulatory submissions
Preparing Rest of World Site GMP registrations and Site Accreditation documentation as well as annual reports for all relevant markets worldwide

To be considered for this role, you will be educated to degree/masters level in Pharmaceutical /Biological/Chemical Science or relevant scientific discipline.

Have at least 5 years work experience in multinational Life Science companies with 2 years relevant experience in the preparation of Module 3 Regulatory documentation for small molecules and/or biologicals or 2 years relevant experience in managing technical files for medical devices.