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Senior Regulatory Affairs Officer

Employer
Thornshaw Recruitment
Location
Dublin (City), Leinster (IE)
Salary
Neg
Start date
8 Apr 2024
Closing date
30 Apr 2024

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

On behalf of my client, we have a new vacancy for a Senior Regulatory Affairs Officer to join the Dublin team.

 

The Role:

 

We are looking for a team player who also has a strong ability to project manage and navigate the complex EU regulatory system in an independent manner. 

 

 

 

Key Responsibilities

 

Specifically, the role will involve the following:

 

 

 

  • To prepare and project manage high quality registration dossiers for approval by Regulatory Authorities in Europe. Monitor the progress of New Product Development, Renewal and Re-Authorisation submissions, respond to queries as they arise and ensure that regulatory requirements are met in a planned and timely manner to avoid delays in approval. Represent the company on Task Forces, Data Sharing Groups, and Industry Forums. Commission studies with Contract Research Organisations. Monitor progress of studies to ensure target dates are maintained. Contribute towards development of Regulatory Strategy. Keep up to-date with national and EU regulatory guidelines.

 

 

Qualifications & Experience:

 

 

 

  • A bachelor’s degree, in science or a related discipline. 5+ years’ experience in European Regulatory Affairs Experience with both active substances and products Detailed understanding of IT Systems and Database Administration desirable

 

 

 

 

For full details send your CV to tdunne@thornshaw.com or call Tina at +353 1 2784701

 

Thornshaw Scientific is a division of the CPL Group www.thornshaw.com

 

 

 

#LI-TD1

 

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

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For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

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