Regulatory Affairs Specialist – CMC

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Regulatory Affairs Specialist – CMC

Candidate should have a strong knowledge and experience of working with life-cycle management (LCM) of the quality documentation for drug products and drug substances.

Key Responsibilities:

As Regulatory Affairs CMC Specialist, you will be working with life-cycle management of the quality documentation for some of company’s approved drug products and drug substances. You will perform regulatory assessment of change control cases, prepare regulatory strategies for variation applications and participate in the preparation of the quality documentation for various submissions. You will also be involved in obtaining approvals in new markets and support renewal applications. You will work in RA product teams where you in close cooperation with other Regulatory Affairs colleagues will plan and project-manage CMC related aspects regarding submissions of variations. You will be part of a cross-functional team, which have the responsibility to create and maintain the quality documentation and handle CMC-related issues for the drug products and drug substances.

You will also take part in the general activities in the department, including improving and implementing integrated regulatory business processes and share new Regulatory Intelligence knowledge.

Experience & Qualifications

We expect you to have:

• 3 years+ experience from Regulatory Affairs within CMC development or life-cycle management of approved products

• knowledge of regulatory requirements within EU – preferably also in other major markets and countries outside EU

• clear focus on agreed objectives, even when working with tight deadlines

• Scientific Master degree, bachelor degree or similar work experience;

• 3 years+ experience from Regulatory Affairs within CMC development or life-cycle management of approved products

• knowledge of regulatory requirements within EU – preferably also in other major markets and countries outside EU

• clear focus on agreed objectives, even when working with tight deadlines

Furthermore, you are:

A strong communicator, passionate and enthusiastic in your way of working, a professional with positive and proactive influencing skills with the ability to take ownership, a strong and proactive team player who thrives on working in an international environment, a professional who can motivate others to adapt to new processes and understand how to build efficient working relationships with both internal and external stakeholders.    

If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

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