Forgot your Password?
Find this page useful? Click

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.

Google Chrome
Internet Explorer
Mozilla Firefox

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Apply for this job






Salary Expectations:



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

CMC Regulatory Senior Scientist

Reference:SCA013719 Location: Cork
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

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.


  • 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


  • 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 or +353879500821