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
Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
Connect with me on
Quality Engineer
Limerick
Process Engineer
Limerick
Qualified Person
Waterford
QA Manager
Cavan
R&D Manager
Galway
Project Engineer
Limerick
QC Scientist
Limerick
Project Engineer
Limerick
Process Engineer
Dublin North
Project Engineer
Limerick
Validation Lead
Limerick
R&D Engineer
Limerick City
QA Manager
Dublin
Head of R&D
Galway
R&D Manager
Limerick
C&Q Engineer
Dublin
eClinical Project Coordinator
Republic of Ireland
eClinical Project Manager
Republic of Ireland
Technical Writer
Limerick
Business Program Lead - Remote
Republic of Ireland
Senior R&D Engineer
Limerick City
Senior Planner
Limerick
Clinical Research Associate (CRA)
Republic of Ireland
QP Manager
Dublin
Project Manager
Limerick
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

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 [email protected]
Details

Director Regulatory Affairs


Reference:SCALGD-172723 Location: Dublin
Republic of Ireland
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

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 support to the Clinical Development Team (CDT) and CMC Project Team
  • Handle Scheduled Drug Licenses for the project-related work, both for CMC and Clinical Development activities. This includes obtaining, documenting and storing of external parties’ licenses, supporting shipments of API and study drugs (import/export licenses), supporting clinical trial sites in getting relevant scheduled drug licenses, including the DEA licenses in the U.S
  • Coordinate activities towards the U.S. FDA (IND, Agency meetings, annual reports, NDA) and EMA (CTAs, Scientific Advice, MAA) and expedited programs
  • Develop and maintain effective working relationships with other CDT and CMC Project Team members
  • Contributes to the development of the regulatory timelines, resources, budget, risk, and quality plans
  • Accountable for meeting or exceeding goals for regulatory affairs operations for development projects
  • Ensures all regulatory tracking needs are identified and facilitate reporting to the Senior Management team
  • Ensure maintenance, tracking, and accuracy of regulatory data and milestones
  • Develop or provide regulatory input to the development of CMC non-clinical and clinical study documents, including study protocols and reports, IMPD, and Investigator’s Brochure
  • Keep up to date with local and international regulatory requirements
  • Regularly communicates the regulatory activity status and timelines and escalates unresolved issues appropriately
  • Contributes to responses to study questions or issues from Health Authorities or EC/IRBs, including adaptation of procedures towards the new EU CT Directive, as implemented

Requirements
  • University Degree related to Life Sciences (e.g., human biology, biochemistry, biology, pharmaceutical science, medical doctor, veterinary medicine, chemistry, engineer)
  • Proven regulatory affairs experience in a consultancy, pharmaceutical and/or biotech company of at least 7 years, including:
    • Document owner of full or parts of Common Technical Dossiers (CTD)
    • Identification and selection of investigational sites, interactions with Principal Investigators and KOLs
    • Ethics Committee and Competent Authority submissions
    • Development of timelines, budgets and resource plans in complete and/or partially outsourced settings
    • Experience across a range of therapeutic areas, experience in psychiatry and/or neurology is a benefit
    • Experience of leading/overseeing external vendors (regulatory affairs consultants)
    • Solid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines
    • Updated knowledge of ICH GxP requirements
    • Experience with regulatory support of development of scheduled drugs is a benefit
    • Experience with regulatory support of development of device development is a benefit
    • Experience with IND, NDA submissions in the U.S. and CTA/MAA submissions in Europe is a benefit
  • Self-driven and motivated team player
  • Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
  • Excellent written and verbal interpersonal communication, influencing and customer care skills demonstrated by an ability to present clear instruction/direction to team members
  • Good organization and tracking skills, as well as attention to detail
  • Mandatory fluent English (both oral and written) – other languages are an asset