I'm looking for...

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

Google Chrome
Internet Explorer
Mozilla Firefox

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
Product Specialist (Microbiology)
Republic of Ireland
QA Manager
Dublin North
QA Manager
Dublin West
Snr QA Specialist
Dublin South
Program Manager
Market Access Manager
Dublin City Centre
Dublin City Centre
QA Manager Biologics
Dublin West
QA Manager
Snr Process Engineer
Dublin North
R&D Engineer
Snr QA Officer
Dublin North
Apply for this job






Salary Expectations:



Current Location:

Notice Period:

Write here your cover note:

If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to applications@lifescience.ie

Regulatory Affairs Specialist Remote Working and Part Time Opportunity

Reference:AUMS-421161 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:Part-TimeSalary: Not Disclosed

Regulatory Affairs Specialist Remote Working and Part Time Opportunity
Our client are currently recruiting for a Regulatory Affairs Specialist to join their Dublin based team on a permanent basis. Remote working and part time hours are options for this role.

• Coordinate and communicate critical input and critical timelines and deliverables to company leadership, development function and other key departments to facilitate regulatory submissions, including scientific advise, pre-submission, MA, Amendments, Annual reports, PSUR and post approval Supplements
• Communication of latest regulatory requirements to product development team
• Discussions with and guidance to company leadership and product development functions specific to pipeline products/projects as requested
• Perform detailed regulatory review and assessment of all documents, gather required data as needed to develop/finalize the documents, coordinate and prepare submissions
• Review technical reports, summary documents and change controls (chemistry, manufacturing and analytical controls) for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments.
• Manage, prepare, publish, using eCTD software, well-organized, scientifically sound submissions related to New Marketing Authorizations, Amendments, Annual reports, PSUR and Supplements that comply with applicable regulatory requirements in eCTD format
• Publish submissions on e-submissions platform
• Post-approval variations filing
• Regular interaction with various European regulatory agencies in preparation, pre-approval and post-approval management of products
• Communicate with project coordinators and others at European regulatory agencies (or regulators) including scientific advise, pre-submission, MA, post-approval communication

• Degree in a scientific disciple such as Chemistry, Biology, Pharmacy or other health related field. Master’s degree preferred
• Experience: 7 + years in the Pharmaceutical Industry required
• Hands on experience in leading a variety of Regulatory submission activities (MAs, Post Approval Supplements, PSURs, Annual Reports.)
• Hands on experience in interacting with regulatory agencies. Experience of interaction with agencies in Germany or Netherlands a plus
• Hands on experience on working on eCTD software
• Ability to interpret Regulatory Authority policies and CMC guidance and correctly apply them as appropriate
• Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
• Familiar with a variety of pharmaceutical concepts, practices and procedures and the functioning of a regulatory affairs department
• Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
• Detail oriented and highly organized
• Ability to persevere, collaborate and interact effectively with a variety of personnel including senior management

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252