Reg Affairs CMC Specialist

Job Title: Reg Affairs CMC Specialist
Contract Type: Permanent
REF: 122604
Contact Name: Gerry Kennedy
Contact Email:
Job Published: almost 6 years ago

Job Description

Regulatory Affairs Specialist fast growing young pharma Dublin



  • Are you looking to join a young, fast growing, highly ambitious young pharmaceutical company?



  • Rapid growth in a small business requires individuals who possess a natural `can do `mentality, who will deal effectively with new challenges and where no two days are the same!

The Company is a growth oriented, investment backed organization, with management and staff taking a ?can-do? approach to all day to day activities and projects. In this permanent based newly created role you will have a ?hands-on? approach, strong attention to detail, judgement and decision making, planning and organising skills, as well as the ability to communicate effectively both verbal and written.

Job Spec:



  • This newly-created appointment will be responsible for co-ordinating registration and CMC regulatory support for commercial and development projects.
  • Will ensure that all new licence and variation applications are planned, tracked and obtained in a timely manner in accordance with various FDA submission procedures.
  • Responsibilities:
  • Activities, including planning, writing and reviewing Module 2 and 3 CTD sections of all regulatory submissions (INDs, NDAs, BLAs, meeting requests, and briefing documents).
  • Coordinate the preparation and timely submission of responses to FDA with US based Regulatory Agent. Manage timelines to ensure approvals are timely and development objectives are met.
  • Manage US commercial license maintenance
  • Ensure continued regulatory compliance of products though change control procedure.
  • Ensure all operations are fully compliant with licence details and updated in accordance with relevant guidelines and directives.
  • Ensure up to date files are maintained for all licensed products manufactured and/or released in manufacturing.
  • Review and approval of all new and revised master batch documentation, QC specifications and packaging work orders in line with licence details and relevant SOPs.
  • Identification, compilation and approval of Regulatory SOP?s.
  • Assist in the preparation, review and approval of new artwork.
  • Monitor EU and US CMC regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.

Person Spec

Bachelor of Science Degree qualification a scientific discipline.




  • 3+ years? experience in a pharmaceutical industry.
  • Ideal candidate will have experience in submissions to notified body / regulators (FDA, HPRA, & EU Bodies) for product approval. R.P status a distinct advantage.
  • EU submission experience will be an advantage, but not essential.
  • Ability to work well both on own initiative and across all levels, both internally and externally.
  • Ideally candidates with have strong organization and communication skills, both verbally and in writing.
  • Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.

Cv to 01 2302400