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Contact Info
Karen Shiel
Life Science

+353 1 5079256
[email protected]
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Details

Regulatory Officer


Reference:KS/ANLD-053051 Location: Louth
Republic of Ireland
Qualification:DegreeExperience:1-2 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Our client is an exciting entrepreneurial research & development driven organisation, based in Drogheda. They are seeking a Regulatory Officer for a 9 month contract to cover a maternity leave. This role is responsible for product registration and document control across all global brands and markets. The position requires significant organisation skills, with cross functional engagement to ensure relevant documents are supplied on time and to a high standard.

Role/Responsibilities:

  • Register products for new markets, maintain and submit necessary documentation to local regulatory agencies and ensure continued licence to operate for brands.
  • Manage technical standards and support regulatory product compliance across all brands/markets.
  • Compile Product Information Files and liaise with sales and distribution partners on their requirements for compliance documents and product specifications.
  • Liaise with external agencies to supply information in order to conform to their compliance standards or achieve specific accreditations.
  • Support the defence of challenges from external parties to new or existing claims or any issues relating to our products and brands.
  • Inform management of any regulatory threats or opportunities for their products, working together to define and implement the best approach to new regulatory requirements or challenges.
  • Build relationships with the teams working across all operational regions both internal and external.
  • Streamline processes and build ways of working to ensure smooth regulatory operations of the countries we sell in.
Education/Experience:
  • A minimum of a Bachelor's degree in science or related technical field
  • Experience working in a regulatory compliance role is desirable
  • A basic understanding of the reasons for regulation and compliance guidelines
  • Exhibit strong written and verbal communication skills as well as analytical and organizational skills
  • Self-motivated, ability to prioritise workload with good judgement skills
  • Detail orientated, accurate and excellent record keeping skills

For further details please contact Karen Shiel on 087 7452487 or send CV in confidence to [email protected]