As a Regulatory Affairs Consultant, you will work with our clients on the following missions:
- Perform internal QC of any submission.
- Proactively communicate the status of ongoing projects and submissions to the manager.
- Assist and provide training to others on software tools and publishing procedures.
- The candidate shall have experience with electronic CTD (eCTD) publishing software, as well as an understanding of regulations and guidelines to ensure eSubmissions compliance.
- The candidate must have experience in the Irish and UK market (MHRA, HPRA)
- The candidate will be implementing submission standards where applicable.
- The candidate will be responsible for ensuring that all final electronic deliverables meet current regulatory electronic document requirements and guidance.
- The candidate will have to deal with Questions and answers with British and Irish Health Authorities
- Candidate will prepare submissions and applications in the Common Technical Document (CTD) in electronic formats with some additional paper requirements as appropriate.
- The candidate must also be detail-oriented, thorough, and methodical.
- The candidate shall establish and comply with standard operating procedures for publishing regulatory submissions.
The ideal candidate will be degree qualified with a BS degree or a MS degree with relevant experience. You should be experienced in electronic document management systems, global regulatory submissions, or other experience directly related to Regulatory Operations. As well as this, you must be able to balance multiple tasks simultaneously to achieve goals and satisfy customers.
As a Regulatory consultant, you will also possess the following characteristics:
- Excellent verbal, and written, strong organizational and time management skills and strong attention to detail.
- Must be able to master new technical skills and apply them to projects as the industry, and the company evolve.