Regulatory Affairs Specialist – CMC

Dublin, Ireland Full Time

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Regulatory Affairs Specialist – CMC

 

Do you want to make a difference in a challenging position?

Applications are invited for a position of Regulatory Affairs Specialist within the Regulatory Affairs CMC Department at LEO Pharma, Dublin. Applicants 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 LEO Pharma’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.    

 

About Regulatory Affairs

In RA we are responsible for global regulatory activities from early development throughout the life-cycle of our products in more than 100 countries world-wide. We work closely together with our colleagues across functions and with our affiliates, area offices, partners and consultants.

More than 100 people are currently part of RA which consists of six areas: Regulatory Affairs US, Regulatory Affairs Europe+, Regulatory Affairs International, Regulatory Affairs Projects, Regulatory Operations and Regulatory Business Support. The vacant position is placed in Regulatory CMC, Dublin which is part of Regulatory Operations. There are seven people currently working in Regulatory CMC Dublin (and 16 people in total working in Regulatory Affairs in Dublin).

 

Application, including C.V should be submitted before 15 Feb 2019

 

LEO PHARMA IS AN EQUAL OPPORTUNITIES EMPLOYER

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