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
R&D Manager
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
Clean Utilities Engineer
Carlow
Senior Mechanical Engineer
Dublin
Regulatory Affairs Specialist
Cork
Senior Recruitment Consultant
Republic of Ireland
R&D Director
Galway
Maintenance Planner
Westmeath
Process Engineer
Cork
Sr. Associate - Quality for Computer Sys
Cork
Senior R&D Manager
Athlone
Senior Project Equipment Engineer
Dublin
Quality Specialist
Tipperary
Lead Maintenance Reliability Engineer
Westmeath
Clean Utilities Engineer
Carlow
Validation Engineer
Carlow
Senior R&D Manager/Director
Dublin
QA Engineer
Leitrim
Senior R&D Engineer
Clare
Principal Software Engineer
Athlone
Production Operator
Carlow
Mechanical Technician - 2 Cycle
Carlow
R&D Manager
Galway
Quality Administrator
Offaly
Validation & Verification Engineer
Dublin
Process Engineer
Limerick
Business Manager (Pharma Chemicals)
Westmeath
CQV Lead
Tipperary
Cleaning Validation Specialist
Cork
Senior Technical Specialist - Bioassay
Cork
Senior Recruitment Consultant
Republic of Ireland
Manufacturing Project Engineer
Mayo
Senior Manufacting Engineer
Republic of Ireland
Quality and Regulatroy Manager
Galway
Senior Quality Engineer
Limerick
Chemical Engineer
Tipperary
R&D Engineer
Dublin
Project Manager - Capital Projects
Meath
Senior R&D Engineer
Clare
Principal Process Equipment Engineer
Dublin South
QC Raw Materials and Compendial Associat
Louth
Production Operator
Carlow
R&D Program Manager
Dublin
R&D Engineer
Galway
Senior Maintenance Technician
Carlow
R&D Manager
Galway
Quality Engineer
Athlone
Senior Human Factors Engineer
Dublin
Batch Record Reviewer
Cork
Senior Electronic Engineer
Dublin
Senior Principle Analyst Economic Modell
Cork
Manufacturing Process Specialist
Cork
Technical Specialist - Manufacturing Pro
Cork
EHS Specialist
Cork
Senior Reg Affairs Specialist - Post Mar
Galway
Change Control Coordinator
Carlow
Senior Quality Engineer
Dublin
Quality Technician
Dublin
Injection Moulding Engineer
Athlone
Senior Design Engineer
Dublin
Associate Global Trade Ops
Dublin
Quality Engineer
Galway
Account Manager UK and Ireland
Republic of Ireland
Operational Excellence Technical Special
Cork
Electrical Engineer
Limerick
Process Engineer - Water Formulations
Limerick
Regional Procurement Senior Specialist (
Dublin
Senior Validation Engineer
Cork
Project Engineer
Limerick
Procurement Senior Specialist
Meath
Process Support Specialist
Carlow
Responsible Person (RP)
Republic of Ireland
Senior Operations Engineer
Galway
Senior R&D Engineer
Galway
Maintenance CMMS Engineer
Tipperary
Principal Scientist Global Regulatory Af
Limerick
Maintenance CMMS Engineer
Tipperary
Qualified Person
Limerick
Quality Technician
Dublin
R&D Director
Galway
Technical Specialist - Process Support
Cork
Quality Control Technician
Carlow
Batch Record Reviewer
Cork
Clinical Statistical Analyst
Cork
Head of R&D
Galway
Senior Regulatory Affairs Specialist
Athlone
Manufacturing Technician
Clare
MES Analyst - IT Manufacturing
Limerick
R&D Project Manager
Galway
Senior Project Manager - Process Develop
Cork
Technical Life Cycle & Engineering M
Galway
Biostatistician
Dublin City Centre
Technical Transfer Specialist
Cork
Principal R&D Engineer
Galway
Quality Engineer
Athlone
Senior Quality Engineer-Remote
Republic of Ireland
Qualified Person
Limerick
Strategic Automation Lead
Waterford
Senior R&D Manager
Athlone
Senior R&D Engineer
Dublin
R&D Manager
Galway
Scientific Consultant
Republic of Ireland
Graduate Occupational Hygiene Consultant
Kildare
E&I Turnover Engineer
Carlow
Embedded Software Engineer
Dublin
Medical Device Director
Republic of Ireland
Cleaning Validation Specialist
Cork
Senior Validation Engineer
Limerick
Senior E&I Maintenance Technician
Carlow
Packaging Engineer
Dublin
Commissioning and Qualification Engineer
Cork
Territory Manager - Scientific (Ireland)
Tipperary
Senior Regulatory Affairs Specialist
Athlone
Quality Systems Specialist
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer
Galway
Product Development Engineer
Galway
Lead Manufacturing Biotech Associate
Meath
Cleaning Validation Specialist
Carlow
Recruitment Consultant
Wexford
Associate Quality Specialist
Tipperary
Validation Engineer
Limerick
QC Bioassay Analyst (shift)
Carlow
Senior Manufacturing Engineer - (NC,CAPA
Limerick
Senior Regulatory Affairs Specialist
Clare
Manufacturing Process Owner Lead
Dublin
C&Q Lead
Tipperary
Compliance Specialist
Carlow
Principal/Senior R&D Engineer Cathet
Galway
QA Manager
Canada
Associate QA Specialist (Shift)
Carlow
Regional Program Coordinator - Global Le
Dublin
Senior Electronic Engineer
Dublin
Project Engineer
Republic of Ireland
Senior Operations Engineer
Galway
Supply Chain Manager
Dublin
Senior HVAC Engineer
Dublin
Laboratory Analyst
Tipperary
Project Engineer
Tipperary
Biomedical Engineer
Dublin
R&D Engineer
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Supply Chain Planner (hybrid)
Dublin
Process Support Specialist
Carlow
QA Drug Substance Manufacture Lead
Louth
Senior Equipment Design Engineer
Dublin
Process Validation Engineer
Cork
R&D Senior Program Manager
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Senior Project Manager - Electrical
Dublin
Validation and Verification Engineer
Dublin
R&D Program Manager - Senior
Galway
Associate Quality Specialist
Tipperary
R&D Director
Galway
Product Lead
Dublin
Validation Lead
Dublin South
Product Development Engineer
Galway
Senior Project Engineer - Utilities
Dublin
Cleaning Validation Specialist
Cork
Project/Process Engineer - Purification
Cork
Quality Manager
Dublin
Senior Electronic Engineer
Dublin
Facilities Engineer
Carlow
Recruitment Consultant
Republic of Ireland
R&D Project Manager
Galway
QC Chemistry Analyst (Shift)
Carlow
Project Enginer
Dublin South
Principal R&D Engineer
Dublin
Senior Design Assurance Engineer
Galway
Process Engineer (Shift)
Carlow
Manufacturing Engineer
Wexford
Senior Validation Engineer
Dublin
EHS Project Lead
Cavan
Cleaning Validation Specialist
Cork
Quality Assurance Engineer
Longford
QC Bioanalytical Analyst
Dublin
Sales/Customer Service Administrator
Clonmel
Quality Validation Engineer
Limerick
Quality Management System Specialist
Cork
Operational Excellence Specialist
Meath
Project Manager
Limerick
Cell Culture Analyst
Carlow
Product Development Engineer
Galway
Technical Transfer Lead
Dublin
Technical Transfer Specialist
Cork
R&D Engineer
Galway
Software Design Assurance Engineer
Dublin
Bioprocess Material Associate - Shift
Dublin
Senior Manufacturing Engineer
Cork
Senior Associate Quality Control
Dublin South
QA Lead DS/DP Manufacturing
Louth
Senior R&D Engineer
Galway
R&D Director
Galway
Quality Specialist - Remediation
Louth
Suite Team Delivery Lead
Tipperary
Sr. Associate - Quality for Computer Sys
Limerick
Senior R&D Engineer
Dublin
Senior QC 24/7 Shift
Dublin
Injection Molding Engineer
North Leinster
Validation Engineer
Cork
Senior Associate QA (24/7 Shift)
Dublin
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

CMC Regulatory Senior Scientist


Reference:SCA013719 Location: Cork
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Regulatory Affairs Executive, Regulatory Affairs Manager, Regulatory Affairs Officer, Regulatory Affairs Specialist

CMC Regulatory Senior Scientist
Our client, a global pharma company, are currently recruiting for a CMC Regulatory Senior Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Senior Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration submissions and provide assistance with submission related Ministry of Health responses.


Responsibilities

  • Provide regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate regulatory submission documentation needed to obtain & maintain marketing authorizations
  • Partner with CMC Regulatory Scientists to manage outsourcing activities & contract manufacturers
  • Ensure successful preparation of CMC dossiers and variation packages to support product submissions
  • Provide regulatory leadership and support for products listed as the primary responsibilities
  • Develop, plan and execute appropriate regulatory strategies and on agreed-upon priorities through effective partnership with CMC Regulatory Scientists and other functional representatives
  • Prepare CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements
  • Partner with the CMC Regulatory Scientist to plan and prepare submission content for marketed products to support management of post-approval changes for content reuse for the Rest of the World countries
  • Manage submission timelines with relevant teams (e.g. supply chain, QC, manufacturing, clinical teams), monitor approval status and communicate change status to interested personnel in a timely manner
  • Partner with CMC Regulatory Associates to effectively support product lifecycle maintenance such as site registrations, product & site renewals as well as license expiry, where applicable
  • Manage authoring and content reviews of simple RtQs
  • Review/Approve regulatory documents such as: full and core CMC Dossiers , variation packages, post-approval commitments with health authorities and answers to questions received from health authorities

Requirements

  • Minimum degree in Life Sciences, ideally an advanced degree (MSc, PhD, PharmD preferred), in related biological and life science field
  • Regulatory experience in either a pharmaceutical or biotech
  • Knowledge of regulatory and compliance guidelines in pharma/ biopharma
  • Knowledge of Manufacturing & Quality work processes as well as GMP complianceProven ability to effectively influence within a team
  • Communicate effectively, particularly with the view to influencing and developing in an international matrix environment, hereby demonstrating a wider business perspective
  • Displays conscientious attitude, and possesses excellent verbal and written communication skills
  • Fully proficient in RIM and in using common Microsoft applications to create and present work
  • Good organizational skills, with the ability to prioritize and be self-motivating
  • Work well collaboratively within a team, or as an individual contributor
  • Possesses excellent attention to detail and ability to effectively prioritize
  • Proven effective teamwork skills; Able to adapt to diverse interpersonal s

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