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

Senior Manager (Clinical Quality and Compliance)

Our client, a global leader in the Biopharma Sector & has an exceptional R&D Quality and Compliance team that fosters a phenomenal environment to develop your skills and expertise. Their strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by their diverse and expert team. They are a committed team of highly skilled Quality and Compliance professionals dedicated to helping deliver life-saving therapies for unmet needs. Their collaborative and supportive structure will help you develop your skills...

Location: Dublin,
Senior Manager (Clinical Quality and Compliance)
Dublin Not Disclosed

Regulatory Delivery Excellence Manager

Regulatory Delivery Excellence Manager Our client, a Cork based pharmaceutical organisation are currently recruiting for a Regulatory Delivery Excellence Manager to join their team on a permanent basis. As Regulatory Delivery Excellence Manager you will be responsible for the recruitment, retention and resource assignment of the regulatory associates managing submissions in the Global Regulatory Affairs organization. You will provide leadership, direction, as well as technical / process expertise to the regulatory associates responsible for the regulatory submission management p...

Location: Cork,
Regulatory Delivery Excellence Manager
Cork Not Disclosed

Director Regulatory Affairs

Director Regulatory Affairs Our client, a growing biotech organisation are currently recruiting for a Director of Regulatory Affairs to join their organisation on a permanent basis. As Director of Regulatory Affairs will be responsible for the coordination and the day-to-day support of the regulatory affairs strategy and operational activities of the organisation. You will provide support to both CMC, non-clinical, and clinical development. Responsibilities Coordinate input from external regulatory affairs consultants, identify and close knowledge gaps Provide regulatory...

Location: Dublin, Republic of Ireland,
Director Regulatory Affairs
Dublin Not Disclosed

CMC Regulatory Specialist

CMC Regulatory Specialist Our client, a global pharma company are currently recruiting for a CMC Regulatory Specialist to join their team on a permanent basis.As CMC Regulatory Specialist you will support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance. You will closely with regulatory product representatives providing guidance to them regarding the regulatory documentation, reporting requirements and registration processes in global markets. ...

Location: Cork,
CMC Regulatory Specialist
Cork Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
CMC Regulatory Specialist Cork Not Disclosed
CMC-Development Regulatory Associate Cork Not Disclosed
CMC-Development Regulatory Associate Cork Not Disclosed
CMC-Development Regulatory Associate Cork Not Disclosed
CMC-Development Regulatory Associate Cork Not Disclosed
CMC-Development Regulatory Associate Cork 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