Senior Regulatory Affairs Executive

Job Type:
Permanent
Job Sector:
Scientific
Region:
Europe
Location:
Galway
Salary:
£40,000 to £50,000 per annum
Salary Description:
€40000 - €50000 per annum
Posted:
01/05/2018
Recruiter:
Quanta Consultancy Services Ltd
Job Ref:
20652XG

Are you looking for a step up into a senior position with a well known Pharmaceutical company with offices across the Globe? 

I am currently recruiting for a Senior Regulatory Affairs Executive to work in a permanent position. This is an excellent opportunity to develop your skills and work for a company with great career prospects    

Role Overview

To assist in the process of development of new products, attaining and maintaining Product Marketing Authorisations.
 
Duties and Responsibilities Will Include:

- Compilation of registration dossiers for submission to EU and non-EU regulatory authorities
- Preparation and submission of variation applications to existing MAs
- Pharmacovigilance – preparation of PSURs, logging, investigating and reporting of adverse reactions
- Review of process validation protocols, analytical method validation and stability reports for inclusion in Part II of the dossier
- Review of Drug Master Files
- Writing of reports for European MAs
- Assist in the project management of both internal and external R&D projects
- Artwork review and approval

 Skills and Qualifications Needed

- Scientific qualification and background preferably B.Sc. or equivalent
- Minimum 3 years in a Regulatory/R&D environment preferably with experience of generic applications
- Pharmaceutical / Bio-pharmaceutical / Animal Health experience
- Experience in busy problem solving environment with the ability to work on multiple projects simultaneously

If this sounds like the job for you, please apply now and a representative will be in touch shortly!

To view Quanta's privacy policy, please visit our website

Contact Details:
Quanta Consultancy Services Ltd
Tel: (0) 1442 860 531
Contact: Xanthe Glaysher
Email:

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