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 Electronic Engineer
Dublin
Scientist (hybrid)
Meath
R&D Technician
Galway
Senior Electrical Engineer
Galway
Principal R&D Engineer
Dublin
Senior Regulatroy Affairs Specialsit
Galway
Senior R&D Engineer
Dublin
QC Laboratory Technician
Carlow
Maintenance Engineer
Cork
Principal R&D Engineer
Galway
Applications Scientist
Dublin
R&D Manager
Athlone
Validation Engineer
Cork
Shift Technician (Injection Moulding)
Kildare
Quality Control NPI Senior Associate
Dublin South
Quality Technical Services Manager - 12
Dublin
R&D Director
Galway
Injection Moulding Engineer
Athlone
Technical Transfer Specialist - Remote
Republic of Ireland
Senior Microbiologist
Dublin
Engineering Projects Lead
Carlow
Process Engineer
Limerick
Project Engineer
Republic of Ireland
Senior Quality Engineer
Leitrim
Downstream Manufacturing Engineer
Dublin
Product Development Engineer II
Athlone
QA Engineer
Leitrim
Procurement Senior Specialist
Meath
Product Development Manager
Galway
Aseptic Process Lead
Carlow
Advanced Technologies Manager
Galway
Senior Quality Engineer
Leitrim
Regional Program Coordinator - Global Le
Dublin
Clean Utilities Engineer
Carlow
Technical Transfer Lead
Dublin
Senior Validation Engineer
Limerick
Senior Process Engineer
Cork
Advanced Technologies Manager
Galway
Principal Instrumentation Engineer
Limerick
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Sales Account Manager, EMEA (Medical Dev
Dublin
R&D Engineer
Galway
Quality Systems Specialist
Galway
R&D Manager
Connaught
R&D Engineer
Galway
Project Engineer
Cork
Senior Design Assurance Engineer
Galway
R&D Engineer
Galway
Principal/Senior R&D Engineer Cathet
Galway
R&D Manager
Connaught
Technical Life Cycle & Engineering M
Galway
CQV Lead
Tipperary
Senior Design Engineer
Dublin
Commissioning and Qualification Engineer
Cork
Product Lead
Dublin
Chemical Engineer
Tipperary
Senior Design Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Process Validation Engineer
Cork
Advanced Technologies R&D Manager
Clare
Senior Technical Transfer Specialist
Cork
Senior Engineering Manager
Limerick
Buyer
Wexford
NPI Process Engineer
Carlow
Manufacturing Project Engineer
Mayo
Senior Regulatory Affairs Specialist
Dublin
Injection Moulding Engineer
Leitrim
Principal Software Engineer
Athlone
Senior Equipment Design Engineer
Dublin
Technical Sales Manager (Chemistry)
Westmeath
Senior Product Development Engineer
Galway
Technical Specialist - Process Support
Cork
Senior R&D Engineer
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Clinical Trial Quality Representative
Cork
Sr. Associate - Quality for Computer Sys
Cork
Senior Quality Engineer
Galway
Senior Quality Engineer
Limerick
Senior Electronic Engineer
Dublin
Senior Associate Quality Control
Dublin
Senior Associate QC
Dublin
Validation Specialist - 50/50 remote
Carlow
Senior Operations Engineer
Galway
Senior HVAC Engineer
Dublin
R&D Engineer
Dublin
Senior Validation Engineer
Dublin
Product Development Engineer
Galway
Process Simulation Technical Engineer
Carlow
R&D Manager
Athlone
Senior Microbiologist
Republic of Ireland
QA Manager
Canada
Senior Manufacturing Engineer
Cork
Senior Project Engineer
Cavan
QA Compliance Specialist
Carlow
Maintenance Engineer
Cork
Associate QA Specialist (Shift)
Carlow
Principal Quality Engineer
Galway
Project Manager - Suite Lead
Tipperary
Senior Electronics Engineer
Dublin
Head of R&D
Galway
Senior Maintenance Technician
Carlow
CQV Engineer - SIP Start Up
Denmark
R&D Engineer
Dublin
Senior Equipment Design Engineer
Dublin
R&D Engineer
Galway
Chief Medical Officer
Dublin
Project Manager
Limerick
Senior QC Microbiology (24/7 Shift)
Dublin
Senior E&I Maintenance Technician
Carlow
Senior Operations Engineer
Galway
Technical Transfer Specialist
Cork
Scientist - Process Cleaning
Limerick
Change Control Coordinator
Carlow
Upstream Manufacturing Process Specialis
Cork
QA Manager
Canada
R&D Director
Galway
Associate Director Global Regulatory Aff
Cork
Sourcing Specialist
Tipperary
Principal Engineer
Dublin
Manufacturing Technician
Clare
Senior R&D Manager/Director
Dublin
R&D Manager
Galway
Senior Polymer Development Engineer
Galway
Value Stream Team Leader / Production Su
Wexford
Senior R&D Manager - Lifecycle Manag
Galway
Principal R&D Engineer
Dublin
Senior R&D Engineer
Galway
Project Manager
Galway
Senior Electronic Engineer
Dublin
Senior Validation Engineer
Dublin
Senior Process Engineer
Dublin
R&D Manager
Connaught
Master Data Associate
Limerick
Reliability Engineer
Tipperary
Change Control SME
Cork
Senior Quality Control Associate
Dublin South
Project Engineer
Limerick
Quality Engineer
Athlone
Project Enginer
Dublin South
R&D Engineer
Galway
Supply Chain Manager (hybrid)
Dublin
Principal Engineer
Dublin
Maintenance CMMS Engineer
Tipperary
Materials Management Scientist
Limerick
Principal Process Development Engineer
Galway
Senior R&D Manager
Athlone
Quality Engineer
Athlone
Quality Engineer
Galway
MS&T Bioprocess Engineer
Meath
Manufacturing Project Engineer
Sligo
Senior R&D Engineer
Galway
Senior Process Engineer
Cork
Engineering Business Manager
Dublin
Senior QC Associate
Dublin
Process Chemist
Limerick
Operational Excellence Specialist
Meath
Manufacturing Biotech Associate 24/7 Shi
Meath
Senior Regulatory Affairs Specialist
Athlone
Project Engineer
Clare
C&Q Lead
Tipperary
Facilities Engineer
Carlow
Advanced Technologies R&D Manager
Clare
Clinical Research Program Manager
Galway
R&D Manager
Galway
R&D Engineer
Galway
Technical Transfer Engineer - Drug Subst
Louth
Senior Microbiology Specialist - Greece
Republic of Ireland
Principal Heart Valves Engineer
Galway
Recruitment Consultant
Republic of Ireland
Manufacturing Engineer
Wexford
Senior Director Statistics Data and Anal
Cork
Senior Maintenance Technician
Roscommon
Product Development Technician II
Galway
Quality Specialist
Clare
Quality Specialist
Clare
Microbiology Manager
Dublin
R&D Engineer
Galway
R&D Manager
Galway
R&D Director
Galway
EHS Systems Specialist
Dublin
Senior Design Quality Engineer
Dublin
Senoior Specialist - MS&T
Dublin
R&D Manager
Dublin
Senior Technical Scientist - Technical T
Cork
Technical Transfer Specialist
Cork
Technical Specialist - Manufacturing Pro
Cork
Project Manager - R&D
Galway
Account Manager UK and Ireland
Republic of Ireland
Instrument Specialist
Tipperary
Medical Writer
Cork
Lead Chemistry Analyst
Cork
R&D Engineer
Galway
Senior R&D Engineer
Galway
Quality Engineer
Athlone
Senior Manufacting Engineer
Republic of Ireland
Compliance Specialist
Carlow
Packaging Engineer
Dublin
Senior Validation Engineer
Dublin
R&D Manager
Connaught
Mechanical Technician - 2 Cycle
Carlow
Injection Molding Engineer
North Leinster
Quality Control Technician
Carlow
Project Engineer
Tipperary
NPI Process Engineer
Carlow
Reliability Engineering Specialist
Louth
Quality Specialist
Tipperary
Senior Mechanical Engineer
Dublin
Operations Specialist
Louth
Principal Process Development Engineer
Dublin
Production Operator
Carlow
Product Development Engineer II
Athlone
Project Manager - Capital Projects
Meath
Senior Recruitment Consultant
Republic of Ireland
Manufacturing Technician
Clare
Injection Molding Engineer
North Leinster
Senior Associate Quality Control
Dublin
Production Operator
Carlow
Technology Transfer Specialist (Technica
Cork
Product Development Manager
Galway
R&D Engineer
Clare
Senior R&D Engineer
Clare
Biomedical Engineer
Dublin
Clinical Project Manager
Cork
Senior Recruitment Consultant
Republic of Ireland
Quality Technician
Dublin
Clean Utilities Engineer
Cork
Senior Regulatory Affairs Specialist
Athlone
VP of Operations
Dublin
Embedded Software Engineer
Dublin
Senior Project Engineer
Cavan
Senior QC Associate
Dublin
R&D Manager
Galway
Compliance Engineer
Carlow
Senior R&D Manager
Athlone
Biostatistician
Dublin City Centre
Senior Quality Engineer
Leitrim
Product Development Engineer
Galway
Senior Quality Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
Quality Specialist
Tipperary
Quality Manager - NPI
Dublin
Senior Design Assurance Engineer
Galway
Project Engineer
Roscommon
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

Associate Director Global Regulatory Affairs


Reference:SCA014363 Location: Cork
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Regulatory Affairs Clinical Research, Regulatory Affairs Manager, Regulatory Affairs Specialist

Associate Director Global Regulatory Affairs
Our client, a global pharma company, are currently recruiting for an Associate Director Global Regulatory Affairs to join their team on a permanent basis. People management experience is essential for this role. This role offers hybrid working.

Responsibilities:
People Management:

  • Recruit, develop, and retain a diverse and highly capable workforce
  • Ensure robust individual training plans and timely completion of required training for direct reports
  • Support and enable talent identification and career development that reflects an end-to-end mindsetand demonstrates judgement-based decision making
  • Actively coach and mentor staff, including providing strategic guidance to staff on regulatory andlabelling process questions
  • Empower staff members to make logical decisions, resolve issues and execute tasks
  • Manage workload based on portfolio prioritization and address implications to overall resourcemanagement and strategies
  • Support and encourage a culture of innovation and model inclusivity to ensure diverse voices andideas are heard and considered
  • Provide mentorship for the managers in the team and across the site
Regulatory Delivery:
  • Align regulatory/labelling strategy with molecule team priorities
  • Actively seek out information on the needs of internal and external customers and monitor US andCanadian regulations
  • Remove barriers to ensure labelling and regulatory activities are completed accurately, timely, and incompliance with regulatory and quality system requirements
  • Manage global cross-functional communication and issue escalations to ensure alignment on delivery and execution
  • Utilize regulatory and process knowledge to drive decision-making
  • Partner with quality in both process improvements and deviation management
  • Provide strategic guidance to staff on regulatory process questions
  • Monitor regulations and the external environment as appropriate
  • Provide technical, administrative and operational support for regulatory and labelling-related systems
Requirements:
  • Bachelor’s Degree, preferably in a scientific or health-related field
  • Previous experience, preferably 5 years in a lead role in the pharmaceutical industry
  • Must understand regulatory processes and the interdependencies of various tasks that requirecoordination among cross-functional team members and possibly third parties
  • Experienced people manager
  • Demonstrated ability to communicate effectively (verbally and written) and to motivate and inspireothers
  • Demonstrated flexibility and strong negotiation skills
  • Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
  • Strong problem-solving skills: able to anticipate and recognize systemic problems, diagnose rootcauses and take corrective actions to prevent reoccurrence
  • Proven ability to coach and develop others

For more information please contact Sinéad Cullen on +353879500821 or [email protected]