US/EU Regulatory Affairs Executive

€52000 - €55000.00 per annum
  1. Permanent
Galway, Republic of Ireland
  1. Regulatory Affairs, Operations
Posted: 21/05/2024

This vacancy has now expired. Please see similar roles below...

Hobson Prior is seeking a Regulatory Affairs Executive for the US and EU. This role is to be part of a dynamic team and involves supporting the team to achieve new marketing authorisations and maintain existing ones in line with company strategy. The successful candidate will report to the US/EU Registration Manager.


- Plan regulatory programmes for specific products and set priorities and schedules with the management team.

- Manage the creation of regulatory dossiers for new products for global markets.

- Coordinate the submission and approval of new products through various procedures.

- Provide technical support to production and R&D teams.

- Advise R&D on regulatory requirements for veterinary products.

- Communicate with colleagues in joint ventures companies.

- Negotiate with regulatory bodies on issues during MA assessment and post MA approval maintenance procedures.

- Stay updated with changes in global regulatory requirements.

- Provide technical support to in-house sales team, sales representatives, customers.

- Review and approve change control requests considering their impact on regulatory compliance and product stability.

- Support the registration and searches for Patents and Trademarks for products.

- Prepare reports on your area of responsibility.

- Support the Veterinary Pharmacovigilance team with pharmacovigilance work as required.

Key Skills and Requirements:

- Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands.

- Ability to manage diverse personalities and viewpoints.

- Ability to build relationships and collaborate with others.

- Strategic decision-making within the business.

- Understanding of company finances, resourcing and ultimate aims of the business.

- Strong working knowledge of best practice processes, change management implementation, coaching and mentoring.

- Ability to prioritize key initiatives, drive growth and set targets and KPIs to monitor the performance.

- Positive and proactive personality.

- Practical, action-orientated approach to managing priorities and teams.

- Strong computer skills in MS Office.

- Scientific qualification and background preferably B.Sc. or equivalent.

- Knowledge of EU regulatory submissions.

- Knowledge of GMP quality requirements for EU veterinary products.

- Experience in a busy problem-solving environment with the ability to work to tight deadlines and on one's own initiative.

- Detailed technical knowledge of products and processes.

- Strong Customer Service focus both internally and externally.

- Good command of technical English (both written and spoken).

- Ability to work on multiple projects simultaneously.

Interested or know someone who might be? Reach out to ­­­­ Henry LeLacheur using the following:


📞 01892 337 418

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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