Veterinary Regularity Affairs Executive

HERO

Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Marc Glennon
email contracting@hero.ie

Veterinary Regularity Affairs Executive

Apply Now

Job ID: JOB-12011
BASIC SUMMARY:

This is an opportunity to be part of a dynamic team within the Regulatory Affairs function. We are looking for individuals who will support and drive our client’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.

In this role you will assist in the process of development of new products, attaining and maintaining Product Licences / Marketing Authorisation.

KEY RESPONSIBILITIES:

The functions of the Veterinary Regulatory Affairs Executive include but are not limited to the following:

  • Compilation and submission of VICH regulatory dossiers Parts I-IV for EU National, MRP, DCP and centralized Marketing Authorization (MA) Applications.
  • Compilation and submission of regulatory dossier in other territories.
  • Preparation and submission of renewal and variation applications for existing MA’s
  • Compile, review and liaise with R&D for collecting CMC part of the dossier.
  • Ensure CMC part of the dossier is in compliance with the current EU guidelines and SOPs.
  • Review of Drug Master Files.
  • Review of protocols for bioequivalence, residue and efficacy studies and reports.
  • Writing of Expert Reports for European MA’s and other territories.
  • Responding to queries raised by the regulatory authorities and external customers.
  • Liaise with regulatory bodies on regulatory issues.
  • Artwork review and approval.
  • Transfer of data from Regulatory Dept. to QA, QC, Production.
  • Responding to queries from other departments.
  • Timely and accurate preparation of dossiers for submission and providing response to authority questions.
  • Attention to detail in generation of dossier, expert reports, protocols and study reports.
  • Ability to work on multiple projects simultaneously
  • Communication skills with external and internal customers.
  • Manage all elements of Ecotox studies.
  • Liaising with external CROs/consultants when required.
  • Keeping up to date with changes in regulatory legislation and guidelines.
  • Support the PV team with pharmacovigilance work.

COMPETENCIES:

  • Organisational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication skills.
  • Work in a team with diverse personalities and viewpoints.
  • Ability to build relationships and collaborate with others is vital.
  • Strategic decision-making within the business as an influencer.
  • Being able to understand company finances, resourcing and ultimate aims of the business is important role-modelling.

For further information on this role in Galway please contact Marc Glennon on 086 839 5531 / contracting@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ 

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Marc Glennon

JOB-12011

Apply Now

Veterinary Regularity Affairs Executive

Marc Glennon

Role Type Permanent
Contact Marc Glennon
email contracting@hero.ie
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