Ivowen is hiring
Are you an experienced Regulatory Affairs professional looking for a new challenge in a dynamic and fast-moving consultancy? Then we may be the fit for you. We are currently recruiting for
Senior Regulatory Affairs Officers/Specialists (home-based)
Role and Responsibilities
Exciting opportunities exist for the right people in a dynamic and focused regulatory affairs consultancy company in Clonmel, Co. Tipperary.
The main duties would include but are not be limited to:
- preparing and compiling fully EU CTD compliant marketing authorisation applications (MAAs) using the DCP, MRP and CP procedures
- preparing, compiling, publishing and maintaining eCTD lifecycles
- preparing, compiling and submitting variations
- preparing, compiling and submitting renewals
- preparing, compiling and submitting clinical trial applications, etc.
- writing and signing Quality Overall Summaries and Expert Statements
- reviewing other MAAs for compliance to standards and preparing gap analyses for clients
- providing strategic regulatory advice
- keeping clients up to date with local national requirements
- liaising with regulatory authorities on behalf of client companies as required and represent the client at regulatory authority meetings as required
- provision of training courses in Regulatory Affairs
Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Regulatory Affairs and Drug Development for pharmaceuticals for human and veterinary use. Medical Devices and/or Pharmacovigilance support is also a service provided and any knowledge or experience in this area would be useful. Staying up to date with changing regulatory requirements is expected. On-site placement at a client’s place of business may be required.
- Minimum Life sciences degree (BSc or equivalent)
- Minimum 1 – 2 years relevant experience in Regulatory Affairs is a prerequisite, with a minimum 1-2 years other relevant experience in the pharmaceutical sector such as QA/QC, Compliance, etc.
- Medical Devices and/or Pharmacovigilance experience would also be very beneficial
- Excellent working knowledge of EU and UK regulatory requirements and procedures required
- Familiarity with electronic submissions (eCTD) useful but not a requirement
- Candidates must be familiar with Adobe and MS Office, or equivalent, etc.
- Excellent written and oral communication skills required, attention to detail and ability to handle multi-faceted projects at the same time a distinct advantage
- Salary negotiable and commensurate with experience
- Attractive benefits package
- Flexible working hours and/or part-time position available
- Working from both home and office available
Please send all applications to firstname.lastname@example.org with CV and cover letter outlining your relevant experience. Closing date 10/05/2021. Candidates will be contacted after this date.
NOTE – no recruitment agency approaches please.