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CareerZone Limited

Regulatory Affairs Specialist

CareerZone Limited

  • Offaly / Westmeath / Galway
  • 40000 - 50000
  • Permanent full-time
  • Updated 07/10/2017
  • Aiden
this job is expired
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My Client a Global Pharmaceutical company based in the midlands are recruiting for a Regulatory Affairs specialist.


Regulatory Affairs Specialist


Applications are invited for the position of Regulatory Affairs specialist. This CMC regulatory role will involve the coordination, preparation and maintaining of a variety of regulatory CMC submissions to support both development and commercial products.


Job Description


· Collection, review and preparation of documentation in support of regulatory CMC submissions to regulatory agencies in the EU, US and other international agencies

· Regulatory support for R&D team for development projects

· Regulatory support for third parties for out licencing activities

· Create timelines and tracking deliverables to ensure that all submissions are submitted on-time

· Review and approve change controls related to proposed products/process changes and their impact on specific regulatory applications

· Plan and initiate projects based on consultation with Manager

· Update and maintain regulatory information management system as part of on-going responsibilities

· Attend relevant functional area and project team meetings as required

· Participation in initiatives aimed at improving internal regulatory standards

· Maintain departmental cGMP documentation and participate in cGMP project initiatives





· A minimum of BSc or equivalent degree in scientific discipline.

· Minimum of 2-4 years of relevant regulatory pharmaceutical experience.

· Clear understanding of content and organization of regulatory submissions in eCTD format, as well as ICH and FDA guidance’s.

· Demonstrated track record of hands on experience in writing and reviewing Module 2 and 3 CMC documentation for drug products and drug substances for inclusion in a wide range of global regulatory CMC filings (e.g. DMF, IND, IMPD, MAA, NDA). In particular, previous experience with authoring DMFs is highly desirable.

· Detailed knowledge and interpretation of EU regulations and working knowledge of US and other countries.

· Motivated, self-starter with the ability to work independently with minimal supervision under tight deadlines.

· Ability to work effectively in a team/matrix environment and build productive working relationships within the Regulatory team and other departments.

· Excellent attention to detail

· Strong written and verbal communication skills including presentations.

· Demonstrates a sense of urgency around meeting commitments and timelines.

· Copes with changing priorities and a demonstrated ability to prioritize multiple projects.




Ref: REG21Ca
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