CMC - Regulatory Strategy Manager

Contenu de l'offre CMC - Regulatory Strategy Manager chez Ipsen

CMC - Regulatory Strategy Manager

Title:

CMC - Regulatory Strategy Manager

Company:

Ipsen Pharma (SAS)

Job Description:

Are you an experienced CMC Regulatory Professional with a background in Global CMC-Regulatory Strategy Life-cycle management and new registrations of small molecules?

If so, we are currently recruiting for a CMC-Regulatory Strategy Manager to join our Technical Operations Global CMC Regulatory Strategy team. This a permanent position and can be based at any of the following Ipsen locations:  Slough UK, Boulogne France or Dublin Ireland.

The successful applicant will have:

Strong project planning skills and be able to develop and deliver sound CMC-Regulatory strategies for multiple global changes.

The ability to handle multiple priorities and complex projects in a fast-paced environment.

Possess excellent critical thinking, written, verbal and interpersonal communication skills.

The CMC-Regulatory Strategy Manager will be a key member of the Global CMC-Regulatory Strategy team supporting Ipsen’s rapidly growing portfolio of externally manufactured commercial products. They will lead the development of CMC-Regulatory Strategy and manage associated Regulatory activities for assigned commercial product(s) for both lifecycle management and geographical expansion through new MAA registrations . They will also manage the CMC-Regulatory relationship for their assigned product(s) with Ipsen’s Technical Operations External Manufacturing Organisation, Global Regulatory, contract manufacturers and Strategic Alliance partners to ensure alignment of strategy and delivery according to agreed plans.

Your role will also include:

Assessing CMC-Regulatory impact of all changes proposed to the allocated product portfolio, providing strategic regulatory advice, and CMC-Regulatory supporting data requirements for subsequent variations.

Ensuring on-time delivery of agreed CMC-Regulatory strategy for assigned commercial product(s)

Liaising with Subject Matter Experts and coordinate CMC-Regulatory Response to Questions ensuring questions from Regulatory Authorities for our global markets are responded to efficiently and on-time to meet expected submission approval timelines

Monitoring and managing risk in routine CMC-Regulatory Strategy activities

Performing CMC-Regulatory intelligence activities as required and work with cross-functional departments to ensure related operations are compliant

To be considered for this role, you will be educated to degree level in Pharmaceutical /Biological/Chemical Science or relevant scientific discipline. Have at least 8 years work experience in multinational Life Science companies with at least 5 years relevant CMC-Regulatory experience in the lifecycle management of small molecules is essential. Be able to demonstrate experience in the development and implementation of Global CMC-Regulatory strategies for major Regulatory submissions and have proven experience in both internal and external Stakeholder Management.

If you feel that this could be the right next step for you, we would be delighted to consider your application.

#LI-Hybrid

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.

Summary

Location: Boulogne; Dublin; Slough

Type: Full time