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
Job Tools
Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
Connect with me on
Hot Science Jobs
Senior Design Assurance Engineer
Galway
Senior Process Engineer
Cork
Senior Project Engineer
Cavan
Manager R&D
Connaught
Process Engineer
Limerick
Senior Process Engineer
Cork
Responsible Person (RP)
Republic of Ireland
Senior R&D Engineer
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Electronic Design Engineer
Galway
Quality Manager - NPI
Dublin
R&D Engineer
Galway
Head of R&D
Galway
Production Operator
Carlow
Product Development Engineer
Galway
Senior Electronics Engineer
Dublin
Engineering Business Manager
Dublin
Senior Engineering Manager
Limerick
Lead Maintenance Reliability Engineer
Westmeath
Regional Procurement Senior Specialist (
Dublin
Senior Quality Engineer
Dublin
Senior R&D Manager/Director
Dublin
Regulatory Affairs Specialist
Cork
R&D Engineer
Galway
Project Manager - R&D
Galway
Cleaning Validation Specialist
Cork
Quality Management System Specialist
Cork
Quality Technician
Dublin
R&D Manager
Connaught
Senior R&D Engineer
Galway
Senior Human Factors Engineer
Dublin
Senior Quality Assurance Associate (REMO
Dublin
Senior Associate Quality Control NPI
Dublin
Microbiologist
Louth
Senior Manufacturing Manager (hybrid)
Dublin
R&D Director
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior Project Manager - Electrical
Dublin
Manufacturing Process Specialist
Cork
QA Engineer
Leitrim
QC Laboratory Technician (shift)
Carlow
Senior Project Engineer - Utilities
Dublin
Biostatistician
Dublin City Centre
Mechanical Technician - 2 Cycle
Carlow
Senior R&D Manager - Lifecycle Manag
Galway
Quality Control Technician
Carlow
Senior Associate Quality Control
Dublin
Senior Design Assurance Engineer
Galway
Senior Quality Engineer
Dublin
Technical Sales Manager (Chemistry)
Westmeath
Manufacturing Project Engineer
Mayo
R&D Technical Life Cycle & Engin
Galway
Quality Specialist - Remediation
Louth
Batch Record Reviewer
Cork
Project Engineer
Tipperary
Senior Regulatory Affairs Specialist
Athlone
Quality Manager
Dublin
Director of Quality Engineering
Limerick
Injection Molding Engineer
North Leinster
Electrical Engineer
Limerick
Senior Regulatory Affairs Specialist
Athlone
Medical Science Liaison (MSL)
Dublin
CQV Lead
Tipperary
Engineering Projects Lead
Carlow
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Equipment Design Engineer
Dublin
Project Enginer
Dublin South
Senior Recruitment Consultant
Dublin
R&D Manager
Connaught
Principal R&D Engineer
Galway
Senior QC 24/7 Shift
Dublin
Engineering Shift Technician
Dublin
Strategic Planning & Operations Mana
Dublin
Senior Project Manager - Process Develop
Cork
R&D Director
Galway
Senior Equipment Design Engineer
Dublin
Process Simulation Technical Engineer
Carlow
QA Manager
Canada
Senior Maintenance Technician
Carlow
CMC Regulatory Principal Scientist
Cork
Commissioning and Qualification Engineer
Dublin
Instrument Specialist
Tipperary
Director of Global Business Development
Dublin
Injection Moulding Engineer
Athlone
Quality Engineer
Wexford
Process Support Specialist
Carlow
Technical Administrator
Tipperary
Cleaning Validation Specialist
Cork
Cleaning Validation Engineer
Carlow
Project Engineer
Limerick
Remote Process Engineer - Fill Finish
Republic of Ireland
Process Engineer - Water Formulations
Limerick
Senior Product Development Engineer
Galway
Technical Specialist - Analytical &
Cork
Regional Program Coordinator - Global Le
Dublin
Biostatistician
Dublin City Centre
Process Engineer (Shift)
Carlow
Downstream Manufacturing Engineer
Dublin
R&D Engineer
Dublin
Technical Transfer Specialist
Cork
Injection Molding Engineer
North Leinster
Sales/Customer Service Administrator
Clonmel
Associate Global Trade Ops
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
R&D Manager
Connaught
Manufacturing Technician
Clare
Production Operator
Carlow
Product Lead
Dublin
Technical Marketing Manager
Wexford
Technical Transfer Specialist
Cork
Principal Heart Valves Engineer
Galway
Injection Moulding Engineer
Athlone
Product Development Engineer
Galway
Product Development Engineer II
Athlone
Senior Regulatory Affairs Specialist
Westmeath
R&D Manager
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
Documentation Specialist
Cork
Principal Preclinical Scientist
Galway
E&I Turnover Engineer
Carlow
Senior Associate Quality Control NPI
Dublin
Senior Recruitment Consultant
Dublin
Senior Technical Scientist - Technical T
Cork
Quality Engineer
Athlone
Project Manager - Capital Projects
Cork
R&D Engineer
Clare
Senior Recruitment Consultant
Republic of Ireland
Quality Specialist
Tipperary
Software Design Assurance Engineer
Dublin
R&D Engineer
Galway
R&D Manager
Connaught
Senior Associate Quality Control NPI
Dublin
Senior R&D Engineer
Dublin
Injection Moulding Engineer
Leitrim
R&D Director
Galway
Maintenance Engineer
Cork
Senior Quality Engineer
Leitrim
Senior R&D Engineer
Galway
R&D Engineer
Dublin
Project/Process Engineer - Purification
Cork
Senior Director Global Regulatory Lead E
Cork
Senior Associate Quality Control
Dublin South
Business Manager (Pharma Chemicals)
Westmeath
Senior R&D Engineer
Clare
Quality - Tech Transfer Specialist
Cork
Senior Quality Engineer
Galway
Associate Quality Specialist
Cork
Senior Quality Engineer
Leitrim
Project Manager - R&D
Galway
Senior E&I Maintenance Technician
Carlow
Suite Team Delivery Lead
Tipperary
R&D Manager
Galway
QC Laboratory Technician
Carlow
Project Engineer
Republic of Ireland
Senior Regulatory Affairs Specialist
Dublin
Product Development Technician II
Galway
Lead Chemistry Analyst
Cork
Project Engineer
Clare
Senior Electronic Design Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
CSV Engineer - IT Labs
Limerick
NPI Process Engineer
Carlow
Scientific Technical Specialist
Dublin
Product Development Engineer
Dublin
R&D Manager
Galway
R&D Director
Galway
Senior R&D Manager
Athlone
Strategic Automation Lead
Waterford
Bioprocess Material Associate - Shift
Dublin
Maintenance Reliability Engineer
Cork
Manufacturing Engineer
Cork
Senior Associate QA (24/7 Shift)
Dublin
Clean Utilities Engineer
Carlow
Technology Transfer Specialist (Technica
Cork
QC Bioanalytical Analyst
Dublin
Commissioning, Qualification and Valid
Carlow
Senior Validation Engineer
Dublin
Technical Specialist - Process Support
Cork
E&I Turnover Engineer
Carlow
Reliability Engineer
Tipperary
Process Development Engineer
Galway
Batch Record Reviewer
Cork
Associate QA Specialist (Shift)
Carlow
Senior Project Equipment Engineer
Dublin
Medical Device Director
Republic of Ireland
Senior Electronic Engineer
Dublin
C&Q Lead
Tipperary
Senior Project Engineer
Cavan
Commisioning and Qualification Engineer
Cork
Quality Engineer
Athlone
Compliance Specialist
Carlow
Senior Recruitment Consultant
Republic of Ireland
Recruitment Consultant
Republic of Ireland
Senior Recruitment Consultant
Cork
R&D Engineer
Clare
QC Chemistry Analyst (Shift)
Carlow
Account Manager UK and Ireland
Republic of Ireland
Technical Specialist - Manufacturing Pro
Cork
MES Engineer
Cork
Senior Validation Engineer
Limerick
Senior Project Engineer
Cork
R&D Engineer
Galway
Project Manager
Limerick
QA Manager
Canada
NPI Process Engineer
Carlow
Advanced Technologies R&D Manager
Clare
Aseptic Process Lead
Carlow
Lead Maintenance Reliability Engineer
Westmeath
R&D Senior Program Manager
Galway
R&D Program Manager
Dublin
R&D Manager
Galway
Biomedical Engineer
Dublin
Project Engineer - Senior
Cavan
Chemical Engineer
Tipperary
Sr. Associate - Quality for Computer Sys
Limerick
Senior Equipment Design Engineer
Dublin
R&D Engineer
Galway
Clean Utilities Engineer
Cork
Senior Research and Development Engineer
Galway
Principal Scientist Global Regulatory Af
Cork
Senior Manufacting Engineer
Republic of Ireland
Senior Electrical Engineer
Galway
Technical Life Cycle & Engineering M
Galway
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

Senior Director Global Regulatory Lead Early Clinical Development


Reference:SCA014111 Location: Cork
Qualification:DegreeExperience:10+ Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Regulatory Affairs Clinical Research, Regulatory Affairs Consultant, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Specialist

Senior Director Global Regulatory Lead Early Clinical Development
Our client, a global pharma company, are currently recruiting for a Senior Director Global Regulatory Lead Early Clinical Development to joint their team on a permanent basis. As Senior Director Global Regulatory Lead Early Clinical Development you will be the regulatory regional lead for assigned molecules in development. You will be responsible for driving the regulatory strategy for development in the US and Canada from discovery through the start of registration studies. You will partner with other global regulatory scientists to develop and execute global regulatory strategy outside the US and Canada. As Senior Director Global Regulatory Lead Early Clinical Development you will be expected to take reasoned risks and leverage innovative regulatory strategies that can accelerate the development of assigned molecules. This is a very exciting to join a company with a very strong product portfolio and pipeline. This role offers hybrid working.

Responsibilities

  • Provide leadership by developing and executing innovative regulatory strategies
  • Work independently in a role that demonstrates organizational influence within and across functions. For example, influences cross-functional teams on clinical development strategy and trial design
  • Acts as direct liaison with FDA and Health Canada
  • Execute high quality communications with regulators and internal customers to articulate and ensure understanding of the regulatory strategy and complex issues
  • Actively seek to deepen regulatory knowledge through constant learning
  • Readily shares information and regulatory knowledge with others
  • Engage in, influence, and shape external environment initiatives related to portfolio assets
Requirements:
  • Bachelor's degree in scientific area and at least 10 years of industry-related experience in regulatory affairs and/or drug development OR Advanced scientific degree (e.g., PhD, PharmD) with at least 8 years of industry-related experience in regulatory affairs and/or drug development
  • Knowledge of FDA and Health Canada procedures and practices and awareness of evolving regulatory initiatives desirable
  • Demonstrated deep knowledge of the drug development process
  • Demonstrated ability to assess and manage risk in a highly regulated environment
  • Demonstrated strong written, spoken and presentation communication skills
  • Demonstrated ability to negotiate and influence
  • Demonstrated attention to detail
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal s
For more information please contact Sinéad Cullen on +353879500821 or [email protected]