Veterinary Regulatory Affairs Executive
Job ID: JOB-11871
JOB TITLE: Veterinary Regulatory Affairs Executive
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 Companies 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 for the Company Group.
The functions of the Veterinary Regulatory Affairs Executive include but are not limited to the following:
- Compilation of VICH regulatory dossiers Parts I-IV for EU National, MRP, DCP and centralized Marketing Authorization (MA) Applications
- Preparation and submission of renewal applications for existing MA’s
- Preparation and submission of variation applications for existing MA’s
- Review of process validations protocols and reports for inclusion in Part II
- Review of method validation data and stability to be included in Part II
- Review of Drug Master Files
- Review of protocols for bioequivalence, residue and efficacy studies and reports
- Writing of Expert Reports for European MA’s
- Responding to queries raised by the regulatory authorities
- Artwork review and approval
- Transfer of data from Regulatory Dept. to QA, QC, Production
- Responding to customer queries and queries from other departments
- Timely and accurate preparation of dossiers for submission and response to authority questions
- Attention to detail in generation of dossier, protocols and reports
- Ability to work on multiple projects simultaneously
- Communication skills with external and internal customers
- Organisational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication skills.
- Ability to lead a team and manage 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.
- Demonstrate and lead on the values, initiatives and culture of an organisation. Professional expertise.
- A strong working knowledge of best practice processes, change management implementation, coaching and mentoring.
- Proven people management capabilities. Ability to motivate a team and collaborate cross-functional and across geographies
- Demonstrated ability in prioritising key initiatives, driving growth and setting targets and KPIs to monitor the performance
- Positive and proactive person who is energised by having great responsibility
- Practical, action-orientated approach to managing priorities and teams.
- The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
- Strong computer skills in MS Office
- 3rd level qualification
- Degree qualified (preferable but not essential)
- Multinational experience (preferable but not essential)
- 5 years + experience in a regulatory role, pharmaceutical/healthcare experience would be an advantage.
- Excellent written and communication skills.
- Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines
For further information on this role please contact Shane Connolly on 0872197421 or
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