Our client a major multi national here in Galway are looking to hire a Regulatory Affairs Specialist on an initial 12 month contract.
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.
- Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
- May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
- Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
- Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
- Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
- Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
- Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
- Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
- Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
For more information or a confidential discussion about this role please contact Michelle Mc Inerney firstname.lastname@example.org, 091 706 717