Regulatory Affairs Specialist
Job Summary:
This is an excellent opportunity for a seasoned Regulatory Affairs Specialist to contribute to the growth and expansion of our business in Oranmore, Co. Galway. As a key member of our team, you will play a crucial role in assisting with dossier registrations and researching regulatory requirements for our new product pipeline.
Key Responsibilities:
1. Dossier Preparation: Assist in preparing dossiers for submission to regulatory authorities across EU and non-EU countries.
2. Study Protocols: Prepare study protocols, tender them, execute, and receive final reports for trial work.
3. Contract Research Organisations: Coordinate with Contract Research Organisations to ensure contracted work meets specifications and timelines.
4. Quality Deliverables: Deliver high-quality work within agreed timelines to meet submission milestones.
5. Data Analysis: Critically analyse complex data and condense it into clear action points.
6. Regulatory Awareness: Maintain knowledge of emerging regulations and guidelines.
7. Problem Solving: Propose and evaluate solutions to regulatory issues; prepare contingency plans.
8. Submission Preparation: Timely and accurate preparation of dossiers for submission and response to authority questions.
9. Attention to Detail: Maintain attention to detail in generating dossiers, protocols, and reports.
10. Project Management: Ability to work on multiple projects simultaneously.
11. Regulatory Guidance: Provide regulatory guidance for new product development when needed; prepare requests for scientific advice.
Competencies and Experience:
1. Scientific Qualification: Hold a qualification in a scientific field, preferably in the life sciences or agricultural area.
2. Regulatory Knowledge: Knowledge of Regulation (EU) No 1107/2009, 528/2012, 2019/1009, and dossier build requirements is advantageous.
3. Organisational Skills: Possess organisational, personal efficiency, time management, and prioritisation skills.
4. Collaboration: Ability to build relationships and collaborate with others.
5. Communication: Strong communication skills with the ability to communicate proposed actions to management.
6. Computer Skills: Possess strong computer skills.
Attitude and Personality:
1. Positive Attitude: Demonstrate a positive 'can-do' attitude with a willingness to succeed.
2. Initiative: Have the ability to work independently and as part of a team.
This is a permanent role based in Oranmore, Co. Galway, offering flexible working hours. The remuneration package includes benefits such as bonus, laptop, phone, pension, maternity/paternity leave, bike-to-work scheme, and training opportunities.