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Market Leader Pharma Generics: Regulatory Affairs Associate II-Dublin

Your new company

HAYS Life Sciences has partnered with a long-standing pharmaceutical company based in Dublin who are actively seeking a Regulatory Affairs Associate on long-term basis to join their state of the art innovation center in South Dublin.
The organization have been in operation for over 50 years and possess an expansive global reach and specialize in the manufacture, distribution and marketing of generic health products in markets across Europe, Asia, Africa and both South & North America.

Your new role

  • Prepare, compile, and submit, new product applications through national, mutual recognition, decentralized or centralized procedures.
  • Prepare, compile and submit variation applications to support changes to authorized details and manage applications through to completion for national, mutual recognition, decentralized or centralized procedures.
  • Prepare, compile and submit renewal applications in accordance with strict deadlines, and manage application through to completion.
  • Update dossiers to mutual recognition standard and progress through national, mutual recognition, decentralized or centralized procedures
  • Preparation of responses to queries from regulatory agencies on new and existing products in conjunction with relevant personnel.
  • Collect, collate, and evaluate scientific data, and present the information in an organized format.
  • Preparation and/or updating of product literature in accordance with regulatory and marketing requirements.
  • Liaise with Regulatory Authorities and external customers/distributors.
  • Interaction with partner companies, distributors and provision of the required documentation.
  • Work closely with all departments, providing regulatory support for the operation and control of the facility.
  • Contribute to cross-functional project teams.
  • Clear communication with relevant departments regarding the changes in registered details.
  • Update / maintain internal databases in relation to the status of on-going tasks.
  • Provide regulatory compliance information within the company in relation to Change Control, Packaging Specifications, Product Literature, and Product Quality Review requirements.
  • Filing and retrieval of regulatory information.
  • Keep abreast of all regulatory legislation and trends in order to provide appropriate guidance / direction to internal and external stakeholders on all areas of regulatory compliance.

What you'll need to succeed

  • Bachelor’s Degree received in scientific area Pharmacology, Chemistry, Biology, Veterinary or similar.
  • 3-4 years’ Regulatory Affairs experience within the Pharmaceutical or related industry.
  • Excellent verbal and written communication skills.
  • Excellent organizational skills with the ability to prioritize and manage projects within a team environment.
  • Strong interpersonal skills, building strong working with relationships with stakeholders both internal and external.
  • Self-motivated with the initiative and resourcefulness to successfully see projects through to completion.
  • Proficient in the use of MS Office tools.
  • Previous experience within the Agri / Veterinary Industry would be advantageous.

What you'll get in return

  • This would be a permanent position with excellent security and competitive benefits.
  • The opportunity to gain broader insight into the overall regulatory process as it will be working within a small compact team of professionals.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.


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