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Job Details

Regulatory Affairs CMC Professional

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LCD9318
Closing Date: 18 Feb 17
Type: Full Time
Salary (£): Negotiable

Job Summary:

On behalf of our client, a global pharmaceutical company, we are currently recruiting for 2 Regulatory Affairs Professionals within the CMC Department.


On behalf of our client, a global pharmaceutical company, we are currently recruiting for 2 Regulatory Affairs Professionals within the CMC Department. These are for a 2 year contract and a 2.5 year contract. Applicants should have a strong knowledge and experience of working with quality documentation for drug products and drug substances. 

Your job 
As Regulatory Affairs Professional you will be working with development and maintenance/ of the CMC documentation for Pharma’s products (Drug Substances and Drug Products). You will perform regulatory assessment of change control cases. You will prepare regulatory strategies and participate in the preparation of the quality documentation to support clinical trial applications (INDs, IMPDs), new marketing authorisations (NDAs, MAAs) and variation applications in global markets. In close cooperation with other Regulatory Affairs colleagues, you will plan and project-manage CMC related aspects regarding submissions. You will be part of a cross-functional team, which has the responsibility to create and maintain CMC documentation for drug substances and drug products. You will participate in and provide regulatory support to project teams looking into development and life-cycle management of the products. 

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

Experience & Qualifications 
•    a relevant scientific degree 
•    2-3 years’ experience from Regulatory Affairs within CMC development or life-cycle management 
•    knowledge of regulatory requirements in EU, US – preferably also in countries outside EU, e.g. Japan 
•    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 
•    a strong and proactive team player who thrives on working in an international environment 

For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671

Apply for this job: Regulatory Affairs CMC Professional

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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