Vacancies


November 2018 – (Senior) Regulatory Affairs Officers/Specialists (office or home-based)

Role and Responsibilities

Exciting opportunities exist for the right person in a dynamic and focused regulatory affairs consultancy company in Clonmel, Co. Tipperary, either on site in Clonmel or working remotely from home or elsewhere.

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 and
  • keeping clients up to date with local national requirements.

Other Responsibilities

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 provided by Ivowen Limited and any knowledge or experience in this area would be useful.  Staying up to date with changing regulatory requirements expected.  On-site placement at a client’s place of business may be required.

Skills/Experience

  • Life sciences degree (BSc or equivalent).
  • Minimum 1-2 yearsrelevant experience in Regulatory Affairs 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 regulatory requirements and procedures required.
  • Familiarity with electronic submissions (eCTD and NEES) useful but not a requirement.
  • Candidates must be familiar with 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.

Benefits package

  • 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.

Closing date

Please send all applications with CV and cover letter outlining your relevant experience to the HR department at jobs@ivowen.com. Closing date 30/11/2018. Candidates will be contacted after this date.
NOTE – no recruitment agency approaches please. Recruitment agency approaches will not be replied to.

 

Regulatory Affairs Consultants Vacancies (on-going)

We are always interested in hearing from regulatory professionals looking to expand their experience and further their career.  There is also the opportunity for managerial responsibility for the right candidate.

Role and Responsibilities

Exciting opportunities exist for the right person 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 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 and
  • keeping clients up to date with local national requirements.

Other Responsibilities

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 provided by Ivowen Limited and any knowledge or experience in this area would be useful.  Staying up to date with changing regulatory requirements expected.  On-site placement at a client’s place of business may be required.

Skills/Experience

  • Life sciences degree (BSc or equivalent).
  • Minimum 3 yearsrelevant experience in Regulatory Affairs 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 regulatory requirements and procedures required.
  • Familiarity with electronic submissions (eCTD and NEES) useful but not a requirement.
  • Candidates must be familiar with 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.

Benefits package

  • Salary negotiable and commensurate with experience.
  • Attractive benefits package.
  • Flexible working hours and/or part-time position available.

Closing date

Please send all applications with CV and cover letter outlining your relevant experience to jobs@ivowen.com.  Prospective candidates will be contacted when vacancies are available.

NOTE – no recruitment agency approaches please. 

Ivowen is always interested in hearing from regulatory professionals with 3+ years relevant experience. Please submit your CV to jobs@ivowen.com

 

pharma med-devices pharma-vigilance training