I'm looking for...
close

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.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
QC Manager
Dublin
Snr QA Specialist
Dublin South
SAP Planner
Galway
QA Manager
Dublin
QA Manager
Dublin North
Quality Engineer
Dublin South
Risk Manager
Dublin
Consultant
Cork
Project Engineer
Dublin North
R&D Engineer
Galway
QA Manager
Meath
Program Manager
Westmeath
QA Manager Biologics
Dublin West
Supply Chain Analyst
Dublin North
National Sales Representative
Republic of Ireland
Biostatistician
Dublin City Centre
Buyer
Dublin
CTO
Galway
R&D Engineer
Dublin
Administration Support
Dublin North
QA Manager
Dublin West
API Purchaser
Dublin
Quality Assurance Manager
Republic of Ireland
Consultant
Brian Christensen
Life Science

+353 (0)1 685 47 47
Connect with me on
Close

Sign up for Regulatory Affairs Manager jobs email alerts

Email *


Frequency of Alert *

Daily Weekly Monthly
Search Results for Regulatory Affairs Manager
Job Title. Location Salary Actions

Quality Assurance and Regulatory Affairs Manager

Quality Assurance and Regulatory Affairs Manager Our client, one of the largest biomedical innovator based in Dublin is looking to recruit QA/RA Manager wh

Location: Dublin North,
Quality Assurance and Regulatory Affairs Manager
Dublin North Not Disclosed

Regulatory Affairs & Quality Manager

Regulatory Affairs & Quality Manager Description: Our client is a start-up medical device company based in Galway. They are seeking a highly experienced

Location: Galway,
Regulatory Affairs & Quality Manager
Galway Not Disclosed

Head of Quality & Regulatory Affairs

Head of Quality & Regulatory Affairs Our client a multinational healthcare company currently seeks Head of Quality and Regulatory Affairs. Reporting to Ge

Location: Dublin,
Head of Quality & Regulatory Affairs
Dublin Not Disclosed

Active Devices Product Technical Specialist / Scheme Manager

We are currently working on an exciting opportunity with world renowned notified body. Who are seeking a Technical Specialist/Scheme Manager in the area of Acti

Location: Republic of Ireland,
Active Devices Product Technical Specialist / Scheme Manager
Republic of Ireland Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Regulatory Affairs Associate Westmeath Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Senior Environmental Compliance Manager Dublin Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Regulatory Affairs Associate Westmeath Not Disclosed
Senior Regulatory Affairs Specialist Cork Not Disclosed
Regulatory Affairs Associate Westmeath Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Regulatory Affairs Associate Westmeath Not Disclosed

Regulatory Affairs Manager Career Profile

Regulatory Affairs Manager


This role is normally suited to someone with a minimum of 5 years in a Regulatory setting, ideally more. Management, departmental budgeting, training are some of the keys tasks involved on the non-technical side of the role.

Key Responsibilities

  • Coordinating, compiling and submitting Marketing Authorisation variations for existing approvals
  • Composing and reviewing Pre-IND information packages and NDA packages for registration of prescription products in the US through the FDA
  • Liaise with partner companies as the primary Regulatory Affairs contact for the company to achieve product registration in all new worldwide regions within projected timeframes
  • Regulatory Affairs European project team leader for all new projects
  • Interpreting EU and US regulatory guidelines and procedures and ensuring the regulatory compliance of the company in all new regions Establish and analyse department budget
  • Identify and recommend areas for cost savings from and Regulatory and compliance perspective
  • Provide Regulatory advice and feedback for all internal company departments and external partners
  • Maintain and apply a high level of awareness and understanding of the impact of existing and future planned regulations