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
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

Regulatory Affairs Manager (Food)

Our client is a world leader in the Food sector. They are currently seeking an experienced Regulatory Manager to manage and develop a team of Regulatory Technologists, Senior Technologists and Specialists. The successful person shall improve regulatory processes, ensuring efficient, accurate and timely delivery of technical documentation to customers across EMEA. They will also ensure that products meet national and international legislation requirements. Role/Responsibilities: • Full understanding of relevant regulations globally - with a particular focus on EU, M...

Location: Kildare,
Regulatory Affairs Manager (Food) 		Kildare 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
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Senior Regulatory Affairs Officer Dublin West Not Disclosed
Senior Regulatory Affairs Officer Dublin West Not Disclosed
Senior Regulatory Affairs Officer Dublin West Not Disclosed
Subscribe RSS feed for this search

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